Achieve Proficiency in Facilities Validations

Agenda • Facilities Validation Overview

– Purpose – Facility and Utility Lifecycle Management – Qualification Stages, Impact to Product and Risk Level

• Types of Facilities Validations – Architectural Finishes, Cleanroom Performance, HVAC, CDA, FMS – Outputs applicable per type

• Documenting Facilities Validations

– Protocol and Report Requirements – Deviations

• Maintain the Validated State

– Controls and Change management

• Interactive Exercise – Experiences and lessons learned

Purpose of Facilities Validations

• Guarantee that facility and utility systems are qualified as intended for manufacturing medical devices that meet specifications

Facility and Utility Lifecycle Management

Change Control

Design/Requirements

Build/Commission Validation

Operation Control/Maintenance

Qualification Stages • Design Qualification (DQ): verify the system design is suitable for its

intended purpose and adheres to requirements – System Level Impact Assessment – User Requirement Specifications – Drawings and Engineering Checklists

• Installation Qualification (IQ): verify that system installation adheres to

design requirements and manufacturer specs – Documentation (manuals, PM job plan) – Drawings – System Component – System Instrument Calibration

Qualification Stages • Operational Qualification (OQ): test that the system operates as intended

throughout the operating ranges – System Operation – Operational Parameters – Functional Testing

• Performance Qualification (PQ): test that the system consistently

performs within its critical process parameters for the intended use – Performance Parameters – Sampling locations – System Performance Testing

Evaluation of Quality Impact

Impact Level Description User Requirement

Specs

Commissioning Validation

Direct Expected to directly impact product quality

Required Required Required

Indirect Supports a direct impact

system

N/A Required N/A

No impact Does not impact product

quality at all

N/A N/A N/A

Risk Level for Facility and Utility System

• Level 1: undetectable change in system performance represents risk to the product

• Level 2: detectable change in system performance represents

risk to the product • Level 3: changes in system performance does not represent

risk to the product

Qualification Stages based on Risk Level

Risk Level Qualification Stages System Qualification

Level 1 - DQ, IQ, OQ & PQ - Cleanroom - Utility (gas, water)

Level 2 - DQ, IQ, OQ - PQ based on Risk

- HVAC Mechanical - HVAC Monitoring

Level 3 -IQ - DQ, OQ & PQ based on Risk - Architectural Finishes

Scope of Change Scope Description Requirements (as applicable)

New Validation

- System with no validation package

- Full validation of all requirements

- DQ - IQ - OQ - PQ

Full Addendum - Changes that impact the User Requirements

- New protocol - New report

Partial Addendum - Changes that do not impact User Requirements

- Portions of existing protocol - Abbreviated report

Types of Facilities Validations

HVAC Mechanical

Cleanroom Performance

Gas (Compressed Dry Air)

Architectural Finishes

Facilities Monitoring System

HVAC Mechanical

• Typical Scenarios: – New Facility

– Major changes in the

HVAC system (equipment failures and system upgrades)

HVAC Mechanical

• Installation Qualification: establish that the critical components of the HVAC System are installed correctly and in accordance with applicable design specs

• Operational Qualification: establish, through documented testing, that the HVAC system operates as intended throughout all anticipated ranges

HVAC Mechanical

System Documentation

Drawing & Utility

Air Handling Unit

Ductwork and HEPA Filters IQ V

erifi

catio

ns

HVAC Mechanical

Air handling equipment

HEPA Filter Challenge

Room Air Change Rate

As Built-Temperature, Humidity and Differential Pressure

As Built-Non Viable Particulate

OQ

Ver

ifica

tions

Cleanroom Performance (PQ)

• Purpose: evidence that cleanroom can maintain environmental conditions appropriate for manufacturing

• Outputs: non-viable air particulate, viable air particulate, surface viable particulate and differential pressure

Cleanroom Performance

• Strategy: testing under “At Rest” conditions and under

“Dynamic” conditions

• Testing: representative timeframe to measure outputs

• Typical Scenarios: – New facility – Major changes in the HVAC Mechanical System – Occupancy Re-validation

Cleanroom Performance

Cleanroom Performance Example

Parameter Accept Criteria

Non Viable Air Particulate ≤ 3,520,000 particles/m3 for 0.5 μm ≤ 29,300 particles/m3 for 5.0 μm

Viable Air Particulate ≤ 200 CFU/m3

Viable Surface ≤ 50 CFU/plate

Viable Floors ≤ 200 CFU/plate

Cleanroom Performance Example

Room Name Non Viable Air Particulate

Viable Air Particulate

Viable Surface Viable Floors

Cleanroom # 1 36 36 41 6

4 day Sampling 144 144 164 24

Total Number of Samples

476

Sampling Plan

Cleanroom Performance Example Non Viable Particulate

Viable Particulate

Sample ID Location Acceptance Criteria

0,5 μm particles/m3

Acceptable (Yes/No)

NV1 Southeast Corner ≤ 3,520,000

NV2 South Side ≤ 3,520,000

Sample ID Location Acceptance Criteria CFU/m3 Acceptable

(Yes/No)

V1 Southeast Corner ≤ 200 CFU/m3

V2 South Side ≤ 200 CFU/m3

Cleanroom Performance Example Viable Surfaces

Viable Floors

Sample ID Location Acceptance Criteria

CFU / plate Acceptable (Yes/No)

VS1 Subassembly ≤ 50 CFU/plate

VS2 Line # 1 ≤ 50 CFU/plate

Sample ID Location Acceptance Criteria

CFU / plate Acceptable (Yes/No)

VF1 Front of Hallway Doors ≤ 200 CFU/plate

VF2 Center ≤ 200 CFU/plate

Compressed Dry Air

• Typical Scenarios:

– New facility

– Major changes in the

CDA System (compressor failures, new utility points, piping extensions)

Compressed Dry Air (CDA)

• Installation Qualification: provide evidence that the system was installed in accordance with the applicable design and user specifications

• Operational Qualification: provide evidence that the system

performs as intended throughout the anticipated ranges in accordance with the applicable design and user specifications

• Performance Qualification: provide evidence that the system

performs as intended in accordance with the applicable design and user specifications

IQ V

erifi

catio

ns

Drawings

Piping Installation

Valve Identification

Compressed Dry Air

Compressed Dry Air

Operating Procedure Review

Pressure Verification

OQ

Ver

ifica

tions

Compressed Dry Air

Operating Procedure Review

Non Viable Particulate

Viable Particulate

Analytical (Moisture & THC)

PQ V

erifi

catio

ns

Compressed Dry Air Example

Sampling Point

- Non-viable Particulate

0.5 μm: ≤ 3,520,000 μm/m3

5.0 μm: ≤ 29,300 μm/m3

- Viable Particulate

≤ 100 CFU/m3

- Moisture ≤ 128 ppm

- THC ≤ 1.0 mg/m3

LPCDA # 1

LPCDA # 2

LPCDA # 3

Architectural Finishes

• Installation Qualification Purpose: evidence that

architectural finishes were built as intended and are meeting the designs and specifications

• Outputs: Room dimensions, finish details (ceilings, walls, floors), light details, door details, door interlocks

• Accept criteria: outputs must satisfy the User Requirements Specifications

Architectural Finishes

• Typical Scenarios:

– New facility – Major changes in the

facilities (construction remediation, remodeling)

– Major Repairs in the facilities (walls, floors, ceilings)

Architectural Finishes Example

Room Dimensions and Room Volumes Room Name Room Number Room Area

(square feet) Room Volume

(cubic feet)

Cleanroom # 1 11300

Gowning # 1 11301

Cleanroom # 1 – Air Returns Description Specified Actual Acceptable

(Yes/No)

Number of Air Returns 68/Record as Found

Architectural Finishes Example

Cleanroom # 1 – Walls, Ceilings and Floors Description Specified Actual Acceptable

(Yes/No)

Wall Finish Epoxy Painted Gypsum

Floor Finish Smooth and without any gaps

Ceiling Finish Sealed with Caulking

Architectural Finishes Example

Cleanroom # 1 - Room Accessories Description Specified Actual Acceptable

(Yes/No)

Room labeled with room number

Same as description column

Number of Windows

4 / Record as found

Number of Lighting Fixtures

128 / Record as found

Architectural Finishes Example

Cleanroom # 1 – Door # 87

Description Specified Actual Acceptable (Yes/No)

Door between Cleanroom and Corridor

Door opens from Corridor

Door type Single

Door and Frame Material / Finish

Hollow Metal / Epoxy Painted

Facilities Monitoring System (FMS)

• Typical Scenarios:

– New facility

– Major changes in the

system (sensor substitutions, software upgrades)

Facilities Monitoring System (FMS)

• Installation Qualification Purpose: provide evidence

that the hardware and software of the system were installed correctly

• Operational Qualification Purpose: provide evidence

that the hardware and software operates as intended throughout the anticipated ranges

Facilities Monitoring System

System Documentation

Drawing & Utility

Server and Workstation Hardware and Software

Trend and Alarm Configuration

Remote Notification Configuration

IQ V

erifi

catio

ns

Facilities Monitoring System

Alarm Limit Testing

Trend Data

Graphics

Tower Light Functionality

OQ

Ver

ifica

tions

Protocol Documentation Requirements

Purpose and Scope

System Description

Pre-Qualification Documentation

Materials and Equipment

IQ, OQ, PQ (as applicable)

Deviations

Report Documentation Requirements

Executive Summary

Purpose and Scope

Discussion of Results

Deviation Summary

Conclusion

Executed Protocol and Supporting Docs

Dealing with Deviations…

Description of the event

Root Cause Investigation

Resolution Plan

Impact to the Study

Evidence of Completion

Maintaining the Validated State

Deep understanding of the change

Define impact throughout change management system

Outline deliverables to be completed

Interactive Exercise

Let’s discuss about your experiences and lessons learned!!

Contact Information

• Mauricio Chinchilla Romero • Senior Validation Engineer • Abbott Vascular • mauricio.chinchillaromero@abbott.com • (506) 2484 20 79