attachment c · 2016-11-14 · jim mcgrath – finance manager liz tolan – head of quality Éanna...

Attachment C

Management of the Installation

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TABLE OF CONTENTS

1 SITE MANAGEMENT & CONTROL ........................................................ 1

2 ENVIRONMENTAL MANAGEMENT SYSTEM ........................................ 2

3 CALIBRATION & MAINTENANCE SYSTEMS ........................................ 3

4 HOURS OF OPERATION ......................................................................... 3

5 FIT AND PROPER PERSON ................................................................... 4

ISO 14001 Certificate



EHS Policy

Energy Policy

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1 Site Management & Control

Senior management at the AbbVie facility in Cork is as follows:

Mairéad Dunne – Site Director

John Gallagher – Business Excellence Manager

Pauline Morrison – Human Resources Manager

Gary Crowley – Site Engineering Manager

Peter Power – Supply Chain Manager

Jim McGrath – Finance Manager

Liz Tolan – Head of Quality

Éanna Ó Maitiú – Technical Operations Manager

The management structure at the company incorporating the Environmental,

Health & Safety Department (EHS) is detailed in Figure 1.

Figure 1: EHS Department Structure at AbbVie

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The EHS&E Manager is supported by an extensive team of EHS specialists.

Independent expertise will be continually engaged for specific tasks related to

the sites environmental responsibilities (e.g. environmental monitoring and

emissions, maintenance) and certification/auditing requirements (e.g. ISO

14001, ISO 50001, OHSAS 18001 etc.).

2 Environmental Management System

AbbVie operates an Environmental Management System in accordance with

International Standard ISO 14001 Environmental Management. A copy of the

latest accreditation certificate No. 2009/764 is included with this attachment.

AbbVie prepares an annual Environmental Management Programme, which is

fully integrated into the site management system. Targets are set, for between

one and five years, for the programme objectives. At the end of each year the

progress against the targets is formally reviewed at senior management level.

The programmes are adjusted as required in the light of ongoing experience

and advances in knowledge and technology. Targets and goals in the

programmes are set to ensure that resources and systems are put in place to

achieve the targets. The success of the programme is measured by the

effectiveness of the systems installed, as well as results in meeting targets. A

copy of the Annual Environmental Report is made available on request to the

general public.

It is the responsibility of the EHS&E Manager and the site Energy

Champion/CEM to ensure that operations under their control are measured

and monitored. Although the overall management responsibility has been

defined, other managers and key influencers are also assigned responsibility

for components of the systems.

Internal audits are conducted by AbbVie staff throughout the year, with each

area of the operation undergoing a detailed environmental, health and safety

audit by the EHS Department on an annual basis. The Site Leadership Team

annually review the EMS, to ensure its continuing suitability, adequacy and

effectiveness. The management review addresses the possible need for

changes to Environmental, Health and Safety Policy, environmental objectives

and other elements of the environmental management system, in the light of

environmental management system audit results, changing circumstances

and the commitment to continual improvement.

A copy of the AbbVie Environment, Health & Safety Policy and the AbbVie

Energy Policy are included with this attachment. The EHS Manual for the site

is available on request.

AbbVie is also certified as complying with the requirements of OHSAS 18001.

OHSAS 18001 is an international specification which defines a set of

requirements for a comprehensive Occupational Health and Safety

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Management System specification, designed to enable organisations to

manage both their operational risks and improve their performance. A copy of

the certificate is appended to this attachment.

AbbVie also operates an Energy Management System in accordance with

International Standard ISO 50001 Energy Management. A copy of the latest

accreditation certificate is included with this attachment.

3 Calibration & Maintenance Systems

AbbVie has established standard procedures and schedules for the inspection

and calibration of environmental control, abatement and treatment equipment

at the facility.

4 Hours of Operation

The plant operates a combination of days, 24-hours, five and seven day operations. There is a 24-hour security presence on-site at all times.

The plant is in operation at all times of the year. Some parts of the facility

may be subject to short duration shutdown periods for maintenance activities.

These generally occur in the summertime. The plant may opt to cease

operations for short periods such as Christmas or New Year. In all cases there

will be a full time security presence on-site with back up call in systems in the

unlikely event of an incident occurring during these times.

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5 Fit and Proper Person

No employees of AbbVie have been convicted of any offence under the EPA

Acts 1992 and 2003, the Waste Management Act 1996 (as amended), the

Local Government (Water Pollution) Acts 1977 and 1990 or the Air Pollution

Act 1987.

Details of the qualifications, technical knowledge and experience of the

relevant AbbVie employees are given below:

Name Title Role/Responsibility

at AbbVie

Qualifications Years’ Experience

in Environmental

Role

Jens

Buchwald

EHS

Manager

Environmental and

Health & Safety

Management of

Cork Site

Master's degree, Safety

and Environmental

Engineering

Degree Qualified

Environmental, Health

and Safety Professional

with Additional

qualifications in Pollution

Control, Fire Safety,

Waste and Dangerous

Goods.

Over 17 years’

industry experience

across the chemical,

medical device and

pharma industry in

the UK, Germany

and Ireland.

Gary

Crowley

Engineering

Manager

Site Engineering

Manager with

responsibility for the

Engineering and

EHSE functions

MEng, Process Safety

Engineering

MSc, Chemistry

Diploma, Health, Safety

& Welfare at Work

Over 8 years EHS

experience

Provide information to show that the person is likely to be in a position to meet

any financial commitments or liabilities that may have been or will be entered

into or incurred in carrying on the activity to which the application relates or in

consequence of ceasing to carry out that activity.

Attachment K to the main application contains the Decommissioning

Management Plan for the facility. An appropriate financial instrument will be

put in place in due course.

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ISO14001 Certificate

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This is t o certify that the

Environmental Management System Of

AbbVie Cork At

IDA Industrial Estate, Carrigtwohill, Co. Cork

Has been assessed by Certification Europe and deemed to comply w ith the requirements of

ISO 14001:2004 This certificate is val id for the activities specified below:

The manufacture of pharmaceutical products.

Certification of Registrat ion remains the property of Certification Europe Ltd. The val id ity of th is Certificate is maintained o n the condition t hat t he Management System is assessed throug h an

o n-going surveillance program me and continues to adeq uately meet the requ irements of t he standard. To verify this certi f icate valid ity please con tact us at [email protected]

Date of initial cer tification: 7th October 2009 This cert ificate is valid until: 6th October 2018

Chief Executive: Michael Brophy Chairman: Padraic A. W hite

~.c a~-t;_ Signature. ________ _

Client Registration No.: 2009/764 Certificate Reference No.: A/7

Date of certificate issue: 21st October 2015

ISO

CERTIFICATION EUROPE •

Cert1f1cat1on l:urope Ltd Block 20A Beckett Way, Park West Business Park. Dublin 12. Ireland info<ii,certificationeurooe com

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This is to certify that the

Energy Management System Of

AbbVie Cork At

IDA Industrial Estate, Carrigtwohill, Co. Cork

Has been assessed by Certification Europe and deemed to comply with the requirement s of

ISO 50001:2011 This certificate is valid for the activities specified below:

The electricity, gas, transport, and water used within the boundaries of the AbbVie Cork site.

Certification of Registration remains the property of Certification Europe Ltd. The validity of this Certificate is maintained on the condition that the Management System is assessed through an

on-going surveillance programme and continues to adequately meet the requ irements of the standard . To verify this certificate validity please contact us at info@certificat ioneurope.com

Date of initial certification: 14 t h July 2010 This certificate is valid until: 13th July 2019

Chief Executive: Michael Brophy Chairman: Padraic A. White

.,so lia ~~2~L

.. EUROPE

Certification Europe Ltd Block 20A Beckett Way, Park West Business Park, Dublin 12, Ireland info@certificat ioneurooe.com

~ .c. a~t;_ Signature. ________ _

Cl ient Registration No.: 2010/ 1038 Certi ficate Reference No.: A/ 7

Date of Certificate issue: 4th August 2016

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This is to certify that the

Occupational Health & Safety Management System

Of

AbbVie Cork At

IDA Industrial Estate, Carrigtwohi ll, Co. Cork

Has been assessed b y Certificatio n Europe and deemed t o comply w ith the requirements of

OHSAS 18001:2007 This certifi cat e is valid for the acti vities spec ified below:

The manufacture of pharmaceutical products.

Cert ification of Registration remains the property of Certification Europe Ltd. The va lidity of this Certificate is maintained on the condi tion that the Management System is assessed through an

on-going surveillance programme and continues to adequately meet the requirements of the standard. To verify th is certificate validity p lease contact us at [email protected]

Date of initial certification: 7'h October 2009 This certificate is valid unti l: 61h October 2018

Chief Executive: Michael Brophy

s;gnature, ~~ Chairman: Padraic A. White

~,c O.~i{_ Signature. ___ _ _ ___ _

OHSAS

CERTIFICATIO N EUROPE

Cerlif,coliori Europe Ltd Block 20A Beckett Way, Park West Business Park. Dublin 12, Ireland info<a:cert1f1catiooeurooe com

Client Registration No .: 2009/765 Certificate Reference No.: A/6

Date of Cert if icate issue: 21st October 2015

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EHS Policy

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Environmental, Health & Safety Policy

AbbVie (Fournier Laboratories Ireland Ltd.) is a Pharmaceutical Manufacturing and Scale-up Facility dedicated to the supply of Commercial and Clinical Products that enable Abb Vie to deliver a consistent stream of innovative products and therapies that solve serious health issues and have a remarkable impact on people's lives. AbbVie is committed to having a positive impact on societies around the world.

The company considers the safeguarding of the Safety, Health and Welfare of any Worker under the Control of the Organization while performing work or work-related activities and operations; and any Interested Party; person or organisation, that can affect, be affected by, or perceive itself to be affected

by a decision or activity, to be a management priority.

The site policy objectives will be driven by the environmental principles of prevention, reduction, re

use and re-cycle and all reasonable and practicable steps will be taken to provide a safe and healthy environment in addition to safe systems of work. It is therefore the responsibility of AbbVie and all its

employees to adhere to this policy and published global operating policies. In particular AbbVie will conform to the following practices in so far as reasonably practicable:-

• Our Responsible Care policy is a key element in our commitment to Sustainable Development and

Prevention of Pollution. One of our core objectives is to Encourage Energy Efficiency via ongoing management of our key energy aspects and supporting programs. These principles will be driven by top managements' Demonstration of Leadership and the Participation of Workers in the decisionmaking processes

• We are cognizant of our Compliance Obligations through our systematic management of all applicable local, national and international Regulations that relate to Health, Safety and the Environment.

• We are committed to developing a deeper understanding of the Context Of the Organisation, whilst continuing to develop and supply products that, throughout their life-cycle, involve minimum risk to human beings and the environment, while best meeting the needs of our customers.

• We are committed to managing our sites and transportation of our products in such a way as to avoid harm to communities and to our employees, and to minimize the impact of these activities on the environment. We are committed to the Prevention oflnjury and Ill Health at all stages of our processes.

• We are committed to keeping all stakeholders informed of health, safety and environmental issues, and to engage in dialogue with them in a spirit of openness and mutual respect.

• We encourage our joint-ventures, suppliers, sub-contractors and customers to adopt a policy comparable to ours in relation to health, safety and the environment.

• Continual Improvement is a fundamental element of this policy.

This policy is fully supported by Management at all levels of our Organisation and will be reviewed at least annually and u~dirrth:e-seYelopment of Management Objectives, Targets and Programmes.

LQ \ -___________________________ Q: _________ ,

Mairead Dunne, Site Director

Abb Vie Operations Cork

Date

Reference: AbbVie Management Standard - MOO.AV AbbVie Environment, Health and Safety Policy, Clause 4.2 - ISO 14001: 2004 & OHSAS 18001: 2007 and Clause 4.3 - ISO 50001: 2011 & The AbbVie EHS Commitment Policy Statement.

abbvie

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Energy Policy

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Energy Policy

AbbVie (Fournier Laboratories Ireland Ltd) is a pharmaceutical manufacturing facility.

The company acknowledges its duty to ensure that all of its activities are conducted in a responsible and safe manner. It is therefore the responsibility of AbbVie, and all its employees, to adhere to this policy. We have put in place our EnMS in accordance with ISO 50001 standard which is the frame work for setting and review of Energy objectives and targets.

This policy applies to all employees, visitors and contractors. Individual influence and impact on energy procurement, use and conservation will be defined and the appropriate roles, responsibilities and appropriate endorsement and training will be facilitated by senior management.

Management will provide the necessary information and resources to the Energy Committee when and where realistic and achievable opportunities for improvement are identified and the outcomes validated through recognised and auditable measuring protocols.

In particular AbbVie will conform to the following practices in so far as reasonably practicable:

• We have fully endorsed this policy and are fully committed to the entirety of the Energy Management System and Standard within the scope and boundaries of the policy.

• In line with our local and corporate commitment to Operational Excellence we are committed to achieving improved energy performance in all areas.

• Our Responsible Care policy is a key element in our commitment to Sustainable Development and Prevention of Pollution. It applies to all management units and to all employees. One of our core objectives is to Encourage Energy Efficiency via ongoing management of our key energy aspects and supporting programs.

• We are committed to complying with all applicable local, organisational, national and international Regulations and other Requirements that relate to energy aspects and management.

• We are committed to keeping all stakeholders informed on all energy issues, and to engage in dialogue with them in a spirit of openness and mutual respect.

• We encourage our joint-ventures, suppliers, sub-contractors and customers to adopt a policy comparable to ours in relation to energy management and fully support the purchase of energy efficient goods and services.

• We are committed to the availability of resources and information to achieve objectives and targets; these resources may be comprised of the provision of fully competent personnel.

• Continual Improvement in energy performance is a fundamental element of this policy.

This policy is fully supported by management at all levels of our organization and will be reviewed at least annually and used in the development of management objectives, targets and programs.

~ _(ALL _ _ .:;?.:)_~_ Mairead Dunne, Site Director

AbbVie Operations Cork

. _J _ -st __ .t/1 A(c_,, V'\ I lo Date

Reference: ENOO.AV AbbVie Energy Policy, ISO 50001: 201 l(E) Energy Management Standard: Clause 4.3 Energy Policy

abbvie

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Attachment D

Site Operational Description

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TABLE OF CONTENTS:

1 MANUFACTURING ACTIVITIES ON-SITE .............................................. 1

1.1 Site History .......................................................................................... 1

1.2 Company History ................................................................................ 2

1.3 Existing Operations ............................................................................ 3

2 DESCRIPTION OF UNIT OPERATIONS ................................................. 4

2.1 Material Purchasing ............................................................................ 4

2.2 Receipt into Warehouse ..................................................................... 5

2.3 Sampling/Testing by Quality Control ................................................ 6

2.4 Dispensing ........................................................................................... 6

2.5 Milling ................................................................................................... 7

2.6 Granulation .......................................................................................... 7

2.7 Sieving/Sifting ..................................................................................... 8

2.8 Blending ............................................................................................... 9

2.9 Compression ....................................................................................... 9

2.10 Coating ............................................................................................... 10

2.11 Packing .............................................................................................. 10

2.12 Receipt into Warehouse ................................................................... 11

3 PROPOSED PROCESSES .................................................................... 12

4 DESCRIPTION OF PROPOSED UNIT OPERATIONS .......................... 13

4.1 Material Purchasing .......................................................................... 13


4.3 Sampling/Testing by Quality Control .............................................. 14

4.4 Dispensing ......................................................................................... 15

4.5 Blending ............................................................................................. 15

4.6 Cooling ............................................................................................... 16

4.7 Milling ................................................................................................. 16

4.8 Compression ..................................................................................... 17

4.9 Film Coating ...................................................................................... 17

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4.10 Blending of the Coated Tablets ....................................................... 18

4.11 Sieving ............................................................................................... 18

4.12 Encapsulation .................................................................................... 19

4.13 Packing .............................................................................................. 19


5 CLEAN-IN-PLACE (CIP) OPERATIONS ............................................... 21

6 PROCESS EFFLUENT ABATEMENT ................................................... 21

7 EMISSIONS TO ATMOSPHERE ABATEMENT .................................... 22

7.1 Thermal Oxidiser (TO) ....................................................................... 22

7.2 Dust Control Systems ....................................................................... 22

8 PROCESS CONTROL SYSTEM ............................................................ 23

9 MONITORING ........................................................................................ 23

10 WATER SUPPLY SYSTEM ................................................................ 23

11 STORMWATER MANAGEMENT/ FIREWATER AND SPILL

MANAGEMENT ............................................................................................. 24

12 FIRE WATER SUPPLY SYSTEM ....................................................... 25

13 SCALE-UP FACILITY ......................................................................... 26

13.1 Description ........................................................................................ 26

13.2 Emissions .......................................................................................... 26

14 LABORATORY FACILITIES ON-SITE ............................................... 27

14.1 Description ........................................................................................ 27

14.2 Emissions .......................................................................................... 27

15 NOISE ................................................................................................. 28

16 WASTE ............................................................................................... 29

17 ACCIDENT PREVENTION ................................................................. 29

18 CESSATION OF ACTIVITIES ............................................................. 30

19 BAT ..................................................................................................... 31

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1 Manufacturing Activities On-Site

1.1 Site History

AbbVie have been operating the plant since 2013. An overview of the site

history since greenfield development is as follows:

The IDA Industrial Estate was first developed in the 1970’s before which time

the site was used for agricultural purposes. The first commercial activity on

the existing AbbVie site began in 1978, when the site was first developed by

Island Pharmaceuticals for blending and packaging of powder form

pharmaceuticals. Jouvenal Manufacturing took over the site in 1987 and

began production of their anti-biotic nasal sprays in 1988.

In 1997 the site was purchased by the American pharmaceutical company

Warner Lambert. In 2000, the American global pharmaceutical corporation

Pfizer acquired Warner-Lambert. Between 2000 and 2001 the site was

reportedly not used by Pfizer.

In 2001, the site was acquired by Fournier Laboratories. Having secured

planning permission, Fournier began construction of Manufacturing and R&D

facilities in 2002. The site completed production commissioning and went into

full production in May 2004.

In 2005, Fournier Laboratories was acquired by the Belgian chemical

company Solvay. During 2006, there was significant investment and two new

production facilities were constructed. This included the construction of a two-

storey extension to existing manufacturing building comprising of production

and plant space, alterations to the existing gowning suite and associated

works including drainage, hard-standings, bunds, extension to car parking and

roadways and the provision of footpaths.

In 2007 there was an extension to the existing research and development

laboratory building.

In 2010, the American worldwide health care company Abbott Laboratories

completed the acquisition of Solvay Pharmaceuticals, including the Fournier

Laboratories facility in Cork.

In 2013, AbbVie was founded as a global biopharmaceutical company with

focus and capabilities to address some of the world’s greatest health

challenges. AbbVie is a research-based specialty biopharmaceuticals

company with a broad portfolio of medicines, including leadership in

immunology and virology, and a pipeline of breakthrough therapies.

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1.2 Company History

AbbVie Inc. is a global, research-based biopharmaceutical company formed in

2013 following the separation from Abbott.

AbbVie (previously Abbott) has had a presence in Ireland since 1973.

AbbVie are 25,000 people in 170 countries focused on developing new

products and new ways to help people manage some of the most serious

health conditions.

“We are scientists, researchers, communicators, manufacturing

specialists, and regulatory experts. We also are parents, brothers,

sisters, friends, community leaders, volunteers, and more. We have a lot

in common with the people we serve, and we come together every day

to create, discover, and deliver new ways to improve people's health.”

With its 125-year history, the company’s mission is to use its expertise,

dedicated people and unique approach to innovation to develop and market

advanced therapies that address some of the world’s most complex and

serious diseases.

A New Beginning

On January 1, 2013, AbbVie became an independent company as a result of

the distribution by Abbott Laboratories (Abbott) of 100 percent of the

outstanding common stock of AbbVie to Abbott’s shareholders.

AbbVie was incorporated in Delaware on April 10, 2012 and is comprised of

Abbott’s former research-based pharmaceuticals business.

AbbVie’s Registration Statement on Form 10 was declared effective by the

U.S. Securities and Exchange Commission on December 7, 2012.

AbbVie’s common stock began trading ‘‘regular-way’’ under the ticker symbol

‘‘ABBV’’ on the New York Stock Exchange on January 2, 2013.

AbbVie is a global biopharmaceutical company with the focus and capabilities

to address some of the world's greatest health challenges.

AbbVie has the stability, resources, expertise, and passion to discover,

develop, and bring to market ground-breaking science to solve the biggest

health problems that face the world today and tomorrow.

AbbVie is ……

Focused - on developing leading-edge therapies and innovations.

Passionate - AbbVie have the commitment, expertise, and capabilities

to provide life-changing products to patients who need them most.

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Making a Difference - AbbVie combines deep understanding of patient

needs and disease states to deliver treatments that have an impact on

peoples' lives.

The team in Cork is dedicated, talented and adaptable.

1.3 Existing Operations

AbbVie is a research-based specialty global biopharmaceuticals facility. The

facility currently manufactures solid oral dose products for human use at

commercial scale. These products are used to treat a range of therapeutic

areas such as; High Cholesterol, HIV and Hepatitis C. The site also operates

a 1/10th scale-up facility.

The site operates an Environmental Management System certified to ISO

14001, Health and Safety Management System certified to OHSAS 18001

and Energy Management System certified to ISO 50001.

The products currently manufactured on-site are as follows:

1. TriCor (Cholesterol Treatment)

2. TriLipix (Cholesterol Treatment)

3. Cholib (Cholesterol Treatment)

4. Kaletra (HIV Treatment)

5. Viekirax (Hepatitis C Treatment)

6. Aluvia (HIV-1 Treatment)

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2 Description of Unit Operations

The processes employed on-site include milling, blending, granulation, drying,

sieving, tableting, coating and packaging. In general, the product type being

manufactured will also dictate the nature of emissions to the environment,

however there will be typical emissions arising from each unit operation. Such

emissions are summarised in the following unit operation descriptions.

The manufacturing operations may vary depending on the product

specifications, but in general the manufacture of pharmaceutical tablets at the

AbbVie facility comprise the following unit operations.

Material Purchasing

Receipt to Warehouse

Sampling and Testing

Dispensing

Milling

Granulation

Sieving

Blending

Compression into tablets

Coating of tablets

Packing

Receipt into Warehouse

2.1 Material Purchasing

2.1.1 Description

The site Master Scheduler receives a consolidated finished product demand

from the planning centres and external customers. This demand is loaded in

to SAP (the in-process control system) and a Materials Requirement Plan

(MRP) is generated. The MRP will generate requirements per individual

material or component and Purchase Requisitions are generated. The

purchasing department reviews the requisitions and converts them to

Purchase Orders on a monthly basis.

The purchase orders are placed with the approved vendors and the materials

are delivered in accordance with the agreed lead times. Once the material

arrives at the plant it is goods receipted by the warehouse personnel in

accordance with approved cGMP procedures. Materials are sampled as

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required by the Quality Control sampling procedure and once the materials

have been confirmed to meet the required specifications the materials are

approved for use. Once the materials have been successfully goods

receipted the vendor payment process is completed.

An Approved Suppliers List (ASL) is maintained and materials may only be

purchased from approved suppliers. These suppliers are managed through

the Supplier Management Programme and are audited in accordance with this

programme.

2.1.2 Emissions

Air

There will be no significant emissions to air from this operation.

Sewer

There will be no significant emissions to sewer from this operation.

Waste

Waste paper may arise occasionally which will be disposed of as non-

hazardous waste and recycled were possible.

2.2 Receipt into Warehouse

2.2.1 Description

On receipt of delivery the material is received into the warehouse. It is visually

inspected by the Warehouse Operator. The Warehouse Operator enters the

material details onto SAP and labels the material as per Goods Receipt from

Suppliers procedure.

2.2.2 Emissions

Air


Sewer


Waste

Waste arising will primarily be solid in nature comprising hazardous waste

such as damaged materials and non-hazardous fractions of packaging waste.

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2.3 Sampling/Testing by Quality Control

2.3.1 Description

The material is sampled by the Quality Control department in accordance with

Sampling of Raw Materials procedure. The material is tested and assigned a

status in accordance with the Receipt, Testing & Approval of Samples in the

QC Laboratory procedure. Once the material is assigned a status by the

Quality Department, the material is placed in the appropriate location.

2.3.2 Emissions

Air

Air emissions primarily arise in laboratories from fume hoods and similar

systems. All emissions arising are vented to atmosphere as minor emission

points.

Sewer

There will be emissions to sewer from the laboratory operations, including

glassware washers, sinks, etc.

Waste

Waste arising will primarily be hazardous liquid waste including solvent waste,

laboratory chemicals etc. and also solid waste including empty laboratory

containers and bottles, laboratory utensils (pipettes etc.) testing materials etc.

this waste is collected and transported off site for treatment. Non-hazardous

waste including packaging waste and administrative waste will also occur.

2.4 Dispensing

2.4.1 Description

The material is now available to be dispensed. Dispensing is carried out in

accordance with general dispensing procedure. The residual weight (where

applicable) is calculated, and attached to the container.

2.4.2 Emissions

Air

The operation is conducted in a closed environment to contain any dust

emissions arising, which are then directed to the general dust collection

system for that processing area, subject to HEPA filtration and vented to

atmosphere via a designated main emission point.

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Sewer

During cleaning operations, wastewater is discharged to the process

wastewater drainage system in accordance with the conditions of the current

DTS Licence.

Waste

Waste raw materials may occasionally arise, for on-site collection and

storage, prior to disposal as hazardous solid waste.

2.5 Milling

2.5.1 Description

The dispensed extrudate is milled in the mill in accordance with the

appropriate procedure to reduce the particle size.

2.5.2 Emissions

Air

The milling process is conducted in a closed environment to contain any dust




Sewer

Wastewater emissions will arise following rinsing of the milling equipment

which are directed to the process wastewater system on-site and discharged

in accordance with the conditions of the DTS Licence.

Waste



2.6 Granulation

2.6.1 Description

At this stage the Granulation Feed Dispersion is granulated using a Fluid Bed

Dryer. The Granulation Feed Dispersion is coated onto Lactose using the

Fluid Bed Dryer. The resulting granulate is tested for water content to ensure

the correct specification is achieved.

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2.6.2 Emissions

Air

The granulation process is conducted in a closed environment to contain any

dust emissions arising, which are then directed to the general dust collection



Sewer

Wastewater emissions will arise following rinsing of the granulation equipment


in accordance with the conditions of the DTS Licence.

Waste



2.7 Sieving/Sifting

2.7.1 Description

A portion of the milled extrudate along with the dispensed quantities of other

required raw materials are sieved or sifted and then combined with the

remaining milled extrudate.

2.7.2 Emissions

Air




atmosphere via a designated main emission point. There will be no fugitive

emissions to air due to the controlled environment.

Sewer

During cleaning operations, wastewater is discharged to the process

wastewater drainage system in accordance with the conditions of the DTS

Licence.

Waste

A portion of the milled extrudate along with the dispensed quantities of other

required raw materials are sieved or sifted and then combined with the

remaining milled extrudate.

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2.8 Blending

2.8.1 Description

The mixture is charged to an IBC and then blended with extranular excipients

to afford blended material suitable for compression into a matrix tablet. The

Blend is then weighed.

2.8.2 Emissions

Air

This operation is conducted within a closed environment to contain any dust

emissions arising. These emissions are then directed to the general dust

collection system for that processing area, subject to HEPA filtration and

vented to atmosphere via a designated main emission point. There will be no

fugitive emissions to air due to the controlled environment.

Sewer

Vessel rinses generate washwaters, which are directed to the process

wastewater system on-site and discharged in accordance with the conditions

of the DTS Licence.

Waste



2.9 Compression

2.9.1 Description

This blend is then compressed to form uncoated tablets. Tests for weight

(individual and average), hardness, thickness and visual are performed on the

uncoated tablets to ensure they are of the correct quality.

2.9.2 Emissions

Air

All air emission arising vented to the atmosphere via HEPA filtration.

Sewer

There are no direct emissions arising from the compression stage.

Waste

There may be small quantities of waste tablet dusts arising, for subsequent

handling and disposal off-site as hazardous waste.

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2.10 Coating

2.10.1 Description

The uncoated tablets are coated in accordance with the relevant procedural

method. The tablets are tested for mass and are also visually inspected during

the coating process.

2.10.2 Emissions

Air

These emissions are then directed to the general dust collection system for

that processing area, subject to HEPA filtration and vented to atmosphere via

a designated main emission point. There will be no fugitive emissions to air

due to the controlled environment.

Sewer

Equipment and coating pans cleaning rinses will generate wash waters which

are directed to the process wastewater system on-site and discharged in

accordance with the conditions of the DTS Licence.

Waste

There may be small quantities of waste tablets arising, for subsequent

handling and disposal off-site as hazardous waste.

2.11 Packing

2.11.1 Description

The Finished Product tablets or capsules are packed in accordance with

packaging procedures.

2.11.2 Emissions

Air

All emissions arising in the packaging area are vented via general dust

collection systems, prior to emitting to atmosphere via designated main

emission points, and HEPA filtration.

Sewer

There are no emissions to sewer from the packaging operations.

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Waste


such as damaged Finished Product and non-hazardous fractions of packaging

waste.


2.12.1 Description

The finished products are received into the warehouse.

2.12.2 Emissions

Air


Sewer


Waste



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3 Proposed Processes

The application for an Industrial Emissions (IE) licence from the EPA is

necessary to facilitate the production of a new product line, Creon DR (DR

stands for delayed release i.e. the active ingredient is released gradually into

the body). Creon DR is used in Pancreatic Enzyme Replacement Therapy

(PERT) to treat cases involving Exocrine Pancreatic Insufficiency (EPI) due to

Cystic Fibrosis (CF), Chronic Pancreatitis (CP) and other conditions.

Unit operations for this new product line will be similar to those currently used

for existing product which include milling, blending, granulation, drying,

sieving, tableting, coating and packaging. The production of Creon DR will

differ from existing operations insofar as the process requires the use of the

organic solvent Acetone. The volumes of Acetone required annually for the

production of Creon DR has prompted the IE application process.

The manufacture of Creon DR tablets will comprise the following unit

operations:

Material Purchasing

Receipt to Warehouse

Sampling and Testing

Dispensing

Blending

Cooling

Milling of Particles

Compression into Tablets

Solvent Coating of Tablets

Blending of Coated Tablets

Encapsulation into Oral Dose Specification Capsules

Packing

Receipt into Warehouse

The unit operations associated in the Creon DR production process are

described in more detail below.

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4 Description of Proposed Unit Operations

4.1 Material Purchasing

4.1.1 Description

The site Master Scheduler receives a consolidated finished product demand

from the planning centres and external customers. This demand is loaded in

to SAP and a Materials Requirement Plan (MRP) is generated. The MRP will

generate requirements per individual material or component and Purchase

Requisitions are generated. The purchasing department reviews the

requisitions and converts them to Purchase Orders on a monthly basis.

The purchase orders are placed with the approved vendors and the materials

are delivered in accordance with the agreed lead times. Once the material

arrives at the plant it is goods receipted by the warehouse personnel in

accordance with approved cGMP procedures. Materials are sampled as

required by the Quality Control sampling procedure and once the materials

have been confirmed to meet the required specifications the materials are

approved for use. Once the materials have been successfully goods

receipted the vendor payment process is completed.

An Approved Suppliers List (ASL) is maintained and materials may only be

purchased from approved suppliers. These suppliers are managed through

the Supplier Management Programme and are audited in accordance with this

programme.

4.1.2 Emissions

Air


Sewer


Waste




4.2.1 Description

On receipt of delivery the material is received into the warehouse. It is visually

inspected by the Warehouse Operator. The Warehouse Operator enters the

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material details onto SAP and labels the material as per Goods Receipt from

Suppliers procedure.

4.2.2 Emissions

Air


Sewer


Waste


such as damaged materials and non-hazardous fractions of packaging waste.

4.3 Sampling/Testing by Quality Control

4.3.1 Description

The material is sampled by the Quality Control department in accordance with

Sampling of Raw Materials procedure. The material is tested and assigned a

status in accordance with the Receipt, Testing & Approval of Samples in the

QC Laboratory procedure. Once the material is assigned a status by the

Quality Department, the material is placed in the appropriate location.

4.3.2 Emissions

Air



points.

Sewer



Waste






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4.4 Dispensing

4.4.1 Description

The material is now available to be dispensed. Dispensing is carried out in

accordance with general dispensing procedure. The residual weight (where

applicable) is calculated, and attached to the container.

4.4.2 Emissions

Air





Sewer

During cleaning operations, wastewater will be discharged to the process

wastewater drainage system in accordance with the conditions of the IE

Licence.

Waste



4.5 Blending

4.5.1 Description

Different batches of API and PEG 4000 powder are charged to Conical Screw

Blender, and mixed to get a homogenous mixture of PEG and API enzyme

activity throughout.

4.5.2 Emissions

Air

The blending process is conducted in a closed environment to contain any

dust emissions arising, which are then directed to the general dust collection



Sewer

Wastewater emissions will arise following rinsing of the blending equipment

which will be directed to the process effluent system on-site and discharged in

accordance with the conditions of the IE Licence.

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Waste



4.6 Cooling

4.6.1 Description

The material is cooled to room temperature and discharged into containers.

4.6.2 Emissions

Air


Sewer


Waste



4.7 Milling

4.7.1 Description

The granules are then milled to a particle size suitable for compression.

During the milling process the temperature is controlled to below the melting

point of the Polyethylene Glycol (PEG).

4.7.2 Emissions

Air

The milling process is conducted in a closed environment to contain any dust




Sewer

Wastewater emissions will arise following rinsing of the milling equipment


in accordance with the conditions of the IE Licence.

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Waste



4.8 Compression

The milled granules are compressed into minitabs using a rotary tablet press.

4.8.1 Emissions

Air

The compression process is conducted in a closed environment to contain

any dust emissions arising, which are then directed to the general dust

collection system for that processing area, subject to HEPA filtration and

vented to atmosphere via a designated main emission point.

Sewer

Wastewater emissions will arise following rinsing of the press which are

directed to the process wastewater system on-site and discharged in


Waste



4.9 Film Coating

4.9.1 Description

The coating dispersion is manufactured by dissolving Hypromellose Phthalate

in Acetone in a mixing vessel. After complete dissolution of Hypromellose

Phthalate in Acetone the other coating components are added to the polymer

solution in the container. The minitabs are then coated with the enteric coating

solution using Wurster type coater. The coating is performed in multiple

sublots.

The pre-prepared solution is applied to the fluidized bed, using spray nozzles.

The coated pellets are dried in the coater and are discharged into containers.

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4.9.2 Emissions

Air

The coated pellets are heated to remove the Acetone from the coated pellets.

Volatised Acetone is directed to the Thermal Oxidiser where it is chemically

oxidized to form CO2 and H2O.

Sewer

Equipment and container cleaning rinses will generate wash waters which are

directed to the process wastewater system on-site and discharged in


Waste

Equipment cleaning wipes and cleaning waste products will be collected and

handled as hazardous waste. Initial cleanings are disposed as solid

hazardous waste.

4.10 Blending of the Coated Tablets

4.10.1 Description

The dried coated pellets are transferred to the mixer, to produce a

homogenous batch.

4.10.2 Emissions

Air

Dust extraction is provided for emissions arising. As the material is now at the

final product stages, emissions arising are considered negligible.

Sewer

There are no direct emissions to sewer arising from the tablet sorting process.

Waste

Solid waste comprising reject tablets can arise for disposal as hazardous

waste.

4.11 Sieving

4.11.1 Description

The dried enteric coated pellets are separated by using a tumbling sieving

machine with screens to remove any broken / twinned tablets. The sieved

minitabs are sampled, tested for enzyme activity and stored in containers.

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4.11.2 Emissions

Air



Sewer


Waste


waste.

4.12 Encapsulation

4.12.1 Description

The Pancrelipase delayed-release pellets are encapsulated into hard gelatin

capsules on an encapsulator. The target fill weight for a particular batch is

calculate based actual lipase activity in the batch, calculated as a ratio of the

target lipse activity for that dose

Finally, the capsules produced are packed (in-process capsule storage) in

polyethylene bags, which are placed in disposable high density polyethylene

containers.

4.12.2 Emissions

Air



Sewer


Waste


waste.

4.13 Packing

4.13.1 Description

The Finished Product tablets or capsules are packed in accordance with

packaging procedures.

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4.13.2 Emissions

Air

All emissions arising in the packaging area are vented via general dust

collection systems, prior to emitting to atmosphere via designated main

emission points, and HEPA filtration.

Sewer

There are no emissions to sewer from the packaging operations.

Waste


such as damaged Finished Product and non-hazardous fractions of packaging

waste.


4.14.1 Description

The finished products are received into the warehouse.

4.14.2 Emissions

Air


Sewer


Waste



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5 Clean-in-place (CIP) Operations

All process effluent generated at the site is generated by washing of process

vessels, mostly automatic washes (referred to as CIP). CIP washes are

preceded by a flush. IBCs and some parts of equipment are washed manually

in dedicated washing areas.

Certain washes use only hot water, whereas other washes use Oxonia

(sterilising agent) in addition to hot water or CIP95 (a detergent based on

alkali and complexing agents). The cleaning of certain equipment does not

generate a wastewater discharge to sewer. There is no firm schedule or

timing for washing of equipment. Some tanks are washed every day, however

most of the CIP washes takes place after a production run.

Effluent arising from CIP activities will undergo preliminary treatment on-site

comprising load balancing, pH correction and temperature correction prior to

discharge via sewer to the Carrigtwohill Waste Water Treatment Plant

(WWTP).

6 Process Effluent Abatement

The AbbVie facility has an effluent treatment system on-site. The site’s

effluent management system consists of an automated pH neutralisation

system including a balancing tank at the effluent outflow point.

In addition, there is a system for solids separation and removal from the

process effluent stream (lamella clarifier). However, this system is not in

operation as the suspended solids in the effluent are within the limits of the

sites current Discharge License; Licence Number (Reg. Ref.): IW-DTS-

685667-0.

More details information regarding process effluent abatement is presented in

attachment F, Treatment, Abatement & Control Systems.

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7 Emissions to Atmosphere Abatement

In accordance with the requirements of BAT (Best Available Techniques),

AbbVie ensures that preventative measures are taken against atmospheric

pollution and that suitable abatement technologies are implemented to reduce

the impact on the environment.

7.1 Thermal Oxidiser (TO)

The new Creon DR development will result in the installation of a Thermal

Oxidiser (TO) for the abatement of solvent emissions. This thermal oxidiser

will be used for the destruction of solvent fume emissions which are collected

from the Creon DR production building. This abatement system is in line with

the Best Available Techniques (BAT) as outlined in Section 5.2.3 of the 2006

‘Best available techniques for the manufacture of organic fine chemicals’

document. The emissions from this unit will be continuously monitored by a

fixed continuous emissions monitoring system (CEMS) for key parameters to

be agreed with the Agency.

7.2 Dust Control Systems

It is proposed to use HEPA filters to abate particulate matter from main

emission sources. The efficiency of these filters is >99.95% and filter

performance is verified by way of integrity testing (ISO 14644-3:2005).

The Engineering Department is responsible for supervising the integrity

testing of HEPA filters, Air Flow Velocity Measurements and non-specific air

borne particle counts. Testing, review and interpretation of the results is the

responsibility of the approved contractor and the Engineering Department.

Furthermore, spare filter elements and panels are maintained on-site at all

times.

Emissions to Atmosphere and process effluent emissions are detailed in

Section E of the main application.

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8 Process Control System

The Building Management System at AbbVie is used to control the heating,

ventilation and air conditioning (HVAC) equipment serving production areas,

corridors, packaging rooms, offices and utilities buildings. This includes

control of air handling units, heat exchangers, extract fans and some ancillary

equipment.

The system is also used as a utilities tool for monitoring and troubleshooting

various items of equipment. Analogue and digital data can be taken from

almost any equipment containing electronic control equipment and can be

forwarded to the BMS system for remote monitoring and alarm reporting.

9 Monitoring

AbbVie will implement a programme to ensure that all emissions are

monitored in accordance with IE licence requirements. Details of monitoring

points and methodologies are included in section F.2 of the application.

10 Water Supply System

Potable water supply to the facility is provided exclusively by the public water

supply connection to the IDA Business Park water main which is supplied by

Irish Water. There is no water used up in the process, so the water intake

approximates discharged water volumes. All waste water is discharged into

the sewer. There are no discharge points directly to surface water or ground.

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11 Stormwater Management/ Firewater and Spill

Management

All production will take place exclusively within the production buildings and

loading and unloading of materials will only take place on designated hard-

standing areas.

Under the IE Licence AbbVie will be required to implement and maintain an

Environmental Management Programme (EMP) which will include detailed

measures for the prevention of pollutant release to the storm water drainage

system. Preventative measures which are in place at the AbbVie site include

full secondary containment (bunding) of all internal and external vessels

containing potentially polluting materials. These preventative measures will be

applied to all proposed new infrastructure as required, in the form of either

local bunding, or remote bunding. All bunds and underground process

infrastructure will be integrity tested every 3 years.

Procedures are in place for the use, handling and storage of all chemicals on-

site to ensure that the risk of spills is minimised. Training is provided to staff in

relation to the handling and storage of all chemicals on-site to ensure the risk

of spills is minimised.

Regular routine maintenance programmes are in place for the process

equipment, environmental process equipment, continuous monitors,

laboratory equipment and sampling equipment.

The emergency response teams are also trained in containment measures

with respect to spillages including procedures for containment including; use

of spill kits, spill cleaning and safe disposal of clean-up materials.

Storage areas, production facilities and roadways will have impervious

surfaces, which will drain to collection systems. Plant and vehicles serviced

regularly to minimise leaks. Fuels and lubricant will be stored in designated

bunded areas and refuelling of plant will only be permitted in controlled areas

only.

A fire-water risk assessment recently undertaken has concluded that, based

on the assessment and the EPA’s Guidance Note, firewater retention facilities

for the AbbVie site are not required. For more information, refer to the

Firewater Risk Assessment included in Attachment J of this application.

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12 Fire Water Supply System

The existing fire hydrants are supplied via a 200mm Local Authority ductile

iron water main that enters the existing campus at two locations.

The current fire suppression system comprises:

Firewater holding tank 500m3;

2 x Firewater pumps (5.68m3/min): Diesel Fire Pump & Electric Fire Pump;

Automatic Sprinkler System fed by a 500m3 firewater fighting tank (covers all areas of the site, except Chemstore and Waste store buildings);

7 x fire hydrants (H 1 to H7);

150 mm firewater main; and

Fire extinguishers throughout all areas of the site.

It is AbbVie’s policy that, in the event of a fire, the safe-guarding of life takes

precedence over all other matters. AbbVie provides Emergency Response

Teams (ERT) training to all core ERT team members and conduct emergency

drills bi-annually. In the event of a fire, the Emergency Response Plan is

implemented. The plan addresses in depth the actions to be taken in the

event of a fire; gas release; bomb threat; chemical spillage and environmental

incident. It is site policy that there is always an Emergency Response Team

and Leader available to respond to an accident or incident. In the event of a

fire, the primary objectives are extinguishment and containment. Fire

detection, fire protection and firefighting equipment is provided on-site and

maintained in accordance with recognised standards.

The site is serviced by Midleton Fire Brigade, based at Market Green,

Midleton, which is approximately 10 kilometres from the site. In the event of a

fire alarm being raised, travel time from this fire station to AbbVie would be

estimated to be approximately 10 minutes depending on traffic. The site’s

Emergency Response Plan states that it is responsibility of the “site incident

controller” to alert emergency services. Members of Midleton fire station have

visited AbbVie to familiarise themselves with the layout of the facility, location

of services and to offer general advice to management. The AbbVie site

operates 24/5, however there is a 24/7 security presence at the site.

Once an IE licence has been issued, in the event of an accident or incident,

AbbVie will be required to notify as appropriate; the EPA, Local Authority, Fire

Service, Health Service Executive, Gardaí, Health and Safety Authority,

Fisheries Board, Sanitary Authority, Food Safety Authority and/or Harbour

Masters, of all incidents relating to the environment. Approval and guidance

from the EPA will be sought prior to the disposal of materials and retained fire

water.

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13 Scale-Up Facility

13.1 Description

AbbVie is currently operating a 1/10th size scale-up facility to trial the

production of Creon DR.

13.2 Emissions

Air

Particulate matter, including API particulate is generated during the process.

Emissions from the Coater are abated using a HEPA filter. The Mill and

Extruder have vents but are not currently filtered. The Tablet Press and

Encapsulator are vented and filtered.

Sewer

Waste water will be assessed against licence limits before discharge to sewer.

CIP wash water is collected in IBCs for disposal by an approved waste

contractor.

Waste

Waste Acetone Solution is collected separately in drums for disposal by an

approved waste contractor.

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14 Laboratory Facilities On-site

14.1 Description

There are a number of laboratories at the AbbVie facility, which are involved in

quality control, quality assurance testing activities and product development.

Typical laboratory analyses comprise determination of raw material purity,

product assay and dissolution rate test, tests for chemical impurities and

measurement of physical characteristics.

14.2 Emissions

Air



points.

Sewer



Waste






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15 Noise

There have been no issues with noise from the AbbVie facility in recent years.

The activities at this plant operate in accordance with strict environmental

controls and AbbVie demonstrates compliance with these by continuing to

satisfy compliance with the international environmental standard ISO14001.

Along with this, and as part of previous planning conditions, AbbVie is subject

to various environmental conditions as issued by Cork County Council (CCC).

To satisfy one of the requirements of ISO14001 AbbVie is required to carry

out an environmental noise survey at the facility. The purpose of this survey is

to measure the noise levels from the site and assess them against the noise

criteria detailed in their planning conditions.

Condition 6 of a previous planning condition, which relates to noise, stipulates

noise criteria which the facility must adhere to.

“Noise levels emanating from the proposed development when

measured at the site boundaries shall not exceed 55dBA (15 Minute

Leq) between 0800 hours and 2000 hours Monday to Friday inclusive,

and shall not exceed 45dBA (15 minute Leq) at any other time.

Measurements shall be made in accordance with ISO recommendation

R.1996/1 “Acoustics – Description and Measurement of Environmental

Noise, Part 1: Basic Quantities and Procedures.” At no time shall the

noise generated on-site result in an increase in noise level of more than

10dBA above background levels at the boundaries of adjoining

premises. Background noise level shall be interpreted as the mean

minimum sound level at the relevant place and time in the absence of

noise from the premises the subject of the application.

If noise contains a discrete, continuous tone (whine, hiss, screech, hum

etc.), or if there are distinctive impulses in the noise (bangs, clicks,

clatters or thumps), or if the noise is irregular enough in character to

attract attention, a penalty of +5dBA will be applied to the measured

noise level and this increased level shall be used in checking

compliance with the specified levels.”

Previous noise surveys have noted that, in several instances, noise levels at

the site boundary have exceeded the 45dBA limit stipulated in Condition 6.

However, in accordance with the EPA’s document, Guidance Note for Noise:

Licence Applications, Surveys and Assessments in relation to Schedules

Activities (NG4), these areas are classed as non-sensitive locations as they

are not residential. The AbbVie facility is located next to neighbouring

industrial facilities who also contribute to the noise emissions in the immediate

area. Previous noise surveys have advised that in order to provide a more

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reasonable assessment of the noise impact from the facility; noise emissions

from AbbVie should be assessed at the nearest noise sensitive location

(NSL). The closest NSL to the AbbVie facility is the Castle Lake residential

estate which lies approximately 200m to the east. This approach would also

satisfy the methodology in NG4.

AbbVie has never received any complaints relating to noise, or otherwise, and

can demonstrate satisfactorily that noise has never been an issue at the

Carrigtwohill facility.

New equipment suppliers are advised of the noise limits in NG4 and that any

new equipment being installed must meet those limits. Therefore, it is

expected that the existing limits will be met once any new equipment

associated with this application is installed.

16 Waste

Solid and liquid waste (hazardous and non-hazardous) is disposed or recycled

by licensed waste contractors as agreed with the Agency. A full record of all

waste taken off site is maintained in accordance with the national and

European waste legislation.

For more information regarding waste management, refer to Attachment H:

Materials Handling.

17 Accident Prevention

The Emergency Response Plan contains information on the measures in

operation to reduce the impact of an accidental emission or spillage. The

Emergency Response Plan also includes the provisions for response to

accidental emissions and emergency situations which arise outside of normal

working hours i.e. night-time, weekends and holidays. Site Management will

update the Emergency Response Plan to ensure it is adequate to cover any

new equipment installed. It is not anticipated that there will be any significant

additional accident prevention measures to be undertaken in relation to this

development.

For more information regarding Accident Prevention and Emergency

Response procedures, refer to Attachment J: Accident Prevention and

Emergency Response.

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18 Cessation of Activities

AbbVie has prepared a Decommissioning Management Plan as part of its

Industrial Emissions licence application, to ensure that in the event of a

sudden closure, the site would no longer pose a risk to the environment.

Should circumstances arise whereby it becomes necessary to shut down the

facility, then AbbVie would, at a minimum, implement the Decommissioning

Management Plan to ensure that any negative environmental impact is

avoided. The overall strategy of the Plan is to bring the facility to an

environmentally inert state. AbbVie does not intend to remove all equipment,

structures or systems from the site other than certain specialist equipment.

Once of the plant and/or equipment has been decommissioned and

decontaminated, it will then be tested to ensure there is no risk of

environmental pollution remaining. It is proposed that, following

implementation of the Decommissioning Management Plan, the facility would

be decommissioned to a state whereby it would remain suitable for future

industrial use and its condition would not pose a risk to the public.

The Decommissioning Management Plan will be reviewed annually and

updated as required. A copy of the DMP for the AbbVie facility is included in

Attachment K of this application.

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19 BAT

BAT stands for the Best Available Technique. BAT for a particular sector is

defined in the EU BREF (BAT Reference) document. Attachment I.8 of the

application addresses in detail how the facility intends to comply with BAT.

Where a BAT Conclusions document has not been issued by the Commission

(as is the case for the facility in question) then the ‘BAT Conclusions’ chapter

of the relevant BREF should be consulted. As advised by the EPA, in this

case the relevant BAT and BREF documents are as follows:

‘BAT Guidance Note on Best Available Techniques for Solvent Use in

Coating, Cleaning and Degreasing’, EPA, 2008.

‘Reference Document on Best Available Techniques on Surface

Treatment Using Organic Solvents’, EU IPPC Bureau, 2007.

‘Reference Document on Best Available Techniques in Common Waste

Water and Waste Gas Treatment / Management Systems in the Chemical

Sector’ EU IPPC Bureau, 2003.

‘Reference Document on Best Available Techniques for Energy

Efficiency’ EU IPPC Bureau, 2009.

‘Reference Document on the General Principles of Monitoring’ EU IPPC

Bureau, 2003.

‘Reference Document on Best Available Techniques on Emissions from

Storage’ EU IPPC Bureau, 2006.

AbbVie was found to comply with all relevant BAT requirements.

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