hicoflex%20general%20description tcm30 17433

GEA Pharma Systems

GEA Pharma Systems AG Buck

®

Hauptstrasse 145, PO Box 112, CH-4416 Bubendorf, Switzerland Tel. +41 61 936 36 36, Fax. +41 61 936 36 00

[email protected], www.geapharmasystems.com

General Description

Hicoflex® product range

Hicoflex

® General Description

Hicoflex® General Description of 17 GEA Pharma Systems AG

1 TABLE OF CONTENT

1 Table of Content ....................................................................................................................................... 2

2 Contacts .................................................................................................................................................... 3

3 Introduction............................................................................................................................................... 4

4 General Introduction ................................................................................................................................ 5

4.1 Containment ....................................................................................................................................... 6

4.2 Applications ........................................................................................................................................ 6

4.3 Technical Specification ....................................................................................................................... 7 4.3.1 Manufacturing ....................................................................................................................................... 7 4.3.2 Production environment........................................................................................................................ 7 4.3.3 Quality assurance ................................................................................................................................. 7 4.3.4 Temperature and pressure ................................................................................................................... 7

4.4 ATEX .................................................................................................................................................. 8

4.5 Hicoflex® Materials ............................................................................................................................. 8

4.6 Product range ................................................................................................................................... 10 4.6.1 Hicoflex

® Charge Bag ......................................................................................................................... 10

4.6.2 Hicoflex® Charge Bag plus ................................................................................................................. 11

4.6.3 Hicoflex® Adaptor ............................................................................................................................... 12

4.6.4 Hicoflex® Spray Bag ........................................................................................................................... 13

4.6.5 Hicoflex® Spray Bag with drain .......................................................................................................... 13 4.6.6 Hicoflex

® Sample Bag 400 ................................................................................................................. 14

4.6.7 Hicoflex® Sample Bag 1200 ............................................................................................................... 14

4.6.8 Hicoflex® Suction Device ................................................................................................................... 15 4.6.9 Hicoflex

® Opening Tool Pistol (hand-held) ......................................................................................... 15

4.6.10 Hicoflex® Opening Tool (fixed installed) ............................................................................................. 15

4.6.11 Hicoflex® Discharging Station ............................................................................................................ 16 4.6.12 Hicoflex® Charging Station ................................................................................................................ 16 4.6.13 Hicoflex

® Trolley 4” ............................................................................................................................. 17

4.7 Documentation .................................................................................................................................. 17

Hicoflex



2 CONTACTS

Technical Support: Mr. Martin Gafner

Phone No.: +41 61 936 36 39

E-mail: [email protected]

Sales Assistant: Mrs. Elise Bourgeois

Phone no.: +41 61 936 36 81

E-mail: [email protected]

Purchase Order to be sent to: [email protected]

Hicoflex



3 INTRODUCTION

GEA Pharma Systems unites more than 750 people with a clear pharma focus, providing advanced one-stop solutions for solid and liquid dosage forms. The divisions’ portfolio ranges from R&D partnerships via standalone machines to fully integrated production systems. GEA Pharma Systems combines state-of-the-art solutions from leading industry brands such as Buck

® Valves and Hicoflex® for contained materials handling based on their proven

split-valve technology, Courtoy for tablet compression taking advantage of the MODUL™ technology, Niro for spray drying offering unique solutions for inhalation, taste masking, encapsulation and direct compressables, Lyophil for lyophilization where our products range from small laboratory machines up to production systems including Automatic Loading and Unloading Systems (ALUS), Aeromatic-Fielder™ and Collette™ for granulation and drying technologies including the UltimaPro™ Single Pot Processors or for coating the fluid bed Precision Coater™ and introducing the new continuous CONSIGMA™ granulation and drying system as well as the new Multi Purpose FlexStream™ Technology.

Hicoflex® product range

«flexible & disposable system»

Hicoflex



4 GENERAL INTRODUCTION

Hicoflex® (High Containment Flexible) was the first disposable high containment interface for

dust free and safe transfer of solid dosage materials in the market worldwide. Since 2006 does Hicoflex

® offer our worldwide client base the following advantages:

- High contained handling and transfer of solids materials for optimum personnel, environmental and product protection

- Cost efficient handling of potent solid materials

- Limited capital expenditure

- Reduced cleaning cost with an environmental friendly and disposable solution

- Safe, contained, simple and robust handling and storage of solids materials in flexible bags

- Protection of the solids material thus preventing cross-contamination

- Complete and safe filling and emptying of bags suitable for R&D and Production

- Option with wash in place (WIP) before disposing

Hicoflex® consists of two complementary and self-closing half couplings which seal off dust-

tight and independently of each other. In docked position, the two half couplings can be opened by a special engineered Hicoflex

® opening tool for transfer of solids material .

Hicoflex



4.1 CONTAINMENT

Hicoflex® can achieve containment levels with dust concentrations in the air of 1-10 g/m

3

(corresponds to OEB 4), depending on product characteristics. Lower containment levels might be achieved by using the optional Hicoflex® Suction Device which is an additional air extraction unit installed around the point of docking.

4.2 APPLICATIONS

Hicoflex® is in the majority of the applications used for active solids materials transfers in or

out of an isolator, transfer in or out of a milling-, granulation-, drying- process or into a reactor as shown below. These are just a few examples of the wide range of applications were Hicoflex

® is used successfully today.

Hicoflex



4.3 TECHNICAL SPECIFICATION

4.3.1 Manufacturing

The Hicoflex® coupling is bonded to the LDPE film by thermal joint methods such as high

frequency bonding and heat sealing

4.3.2 Production environment

Extrusion of the LDPE film and subsequent production of Hicoflex® products like the Bags is

performed under GMP conditions in a clean room Class 5 according to ISO EN 14644-1. All Hicoflex

® parts in contact with the product are FDA-compliant.

4.3.3 Quality assurance

Every Hicoflex® bonding between the coupling and film is undergoing a visual quality check.

A further destructive test for constant monitoring the quality is carried out according to a specific quality plan. Successful Quality audits have been carried out by current Hicoflex

®

customers.

4.3.4 Temperature and pressure

Hicoflex consumables are made solely from plastics like POM, thermoplastic elastomers

and LDPE film for which reason the temperature range in which Hicoflex® can be operated is

limited. Hicoflex

® shall not be held in environments or handle solids materials below temperatures

of -20°C and exceed temperature of to +50°C. No positive nor negative pressure can be applied to Hicoflex

® consumables. A special device

developed by us may be applied to equalise the different pressure levels (to be quoted separately). For storage of empty bags the following is recommended:

- Maintain storage in dry conditions and keep storage temperature between 15°C and 35°C at a humidity of 45% RH – 75% RH

- Protect the Hicoflex® Consumables from UV radiation

- Prior to usage of the Hicoflex® Consumables, keep it for 48 hours under processing

conditions in order to acclimatize

Hicoflex



4.4 ATEX

Explosion protection "Avoidance of effective ignition sources" Non-conductive / dissipative plastic bags can generate by interaction with solids / (dust / granular) electrostatic "brush discharges". According to TRBS 2153 and CLC/TR50404 these "brush discharges" cannot ignite solids (dust / granular); however, this is not significant for hybrid mixtures. Electrostatic "propagation brush discharges" can ignite solids (dust / granular); however, "propagation brush discharges" can be excluded in this context, unless there is no pneumatically conveyed and as far as the product drops from a height less than 5 meters (TRBS 2153 and CLC/TR50404; "GPS Code of Practice: Ignition source due to static electricity, Dr. M. Glor SWISSI" (15.10.2008)). The characteristics of the handled active solids material (powder) is based on the following:

4.5 HICOFLEX® MATERIALS

The Hicoflex® product range is categorised into Hicoflex

® Consumables and Hicoflex

®

Investments.

Hicoflex® Consumables are Hicoflex

® products considered for single use transfer after

which these are disposed. These includes Hicoflex® Charge Bag, Hicoflex

® Charge Bag

Plus, Hicoflex® Adaptor, Hicoflex

® Spray Bag, Hicoflex® Spray Bag with drain and the

Hicoflex® Sample Bag (intended for one-way-use).

Hicoflex

® Investments are Hicoflex

® products for constant usage which in general do

require very little maintenance. These include Hicoflex® Suction Device, Hicoflex® Opening

Tools, Hicoflex® Discharging Station, Hicoflex® Charging Station and the Hicoflex® Trolley.

Minimum ignition energy with/without additional inductivity (MIE) ≥ 1 mJ

Specific powder flow resistance arbitrary (Ωm)

Ability of spontaneous degradation none

Reaction with water or flammable solvents none

Hicoflex



The standard material used for Hicoflex®

Consumables are:

Description Material Hicoflex®

Consumables

Film LDPE & LLDPE (Low Density Polyethylene and

Linear Low Density Polyethylene)

Hicoflex®

Charge Bags

Hicoflex®

Adaptors

Hicoflex®

Spray Bags

Hicoflex®

Sample Bags

Coupling Hard components POM white

(Polyoxymethylene)

Soft components TPE white (Thermoplastic elastomer)

Handle PE (Polyethylene) or

HDPE (High Density Polyethylene)

Tubes PE (Polyethylene) or

HDPE (High Density Polyethylene)

The standard material used for the Hicoflex®

Investments are:

Description Material Hicoflex®

Investments

Metal parts (product not touched)

Stainless steel (min. 1.4301 / ANSI 304)

Hicoflex®

Opening Tools

Hicoflex® Discharging Stations

Hicoflex® Charging Stations

Hicoflex®

Trolley

Metal parts (product touched)

1.4401/ANSI 316 L

Plastic parts POM black (Polyoxymethylene)

or PX 226 Isocyanat

Plastic parts ABS (Acrylonitrile Butadiene Styrene)

coated (FDA) Hicoflex® Suction Device

Hicoflex



4.6 PRODUCT RANGE

4.6.1 Hicoflex® Charge Bag

One Hicoflex® Charge Bag consists of: two Hicoflex

® Half couplings, a transparent LDPE film

and an incorporated bag hanger.

Following sizes are available:

Part No. Description x (approx.)

7.020.1102 Hicoflex® Charge Bag 1L 400 mm height






x

± 10 mm

Hicoflex® Charge Bag

Hicoflex



4.6.2 Hicoflex® Charge Bag plus

Same technical description as the Hicoflex® Charge Bag with an additional flush devise.

Following sizes are available:


7.020.2104 Hicoflex® Charge Bag plus 5L 480 mm height





Hicoflex® Charge Bag plus

(with flush devise)

x

± 10 mm

Hicoflex



4.6.3 Hicoflex® Adaptor

The Hicoflex® Adaptor is connecting a Hicoflex

® Charge Bag, Hicoflex

® Charge Bag plus,

Hicoflex® Sample Bag or Hicoflex

® Spray Bag to the process. The coupling is connected to

the Tri clamp with a short plastic hose, made out of the same film as Hicoflex® Charge Bags.

Hicoflex

® Adaptors are available with Tri clamp outside diameters of 2”, 4” and 6”. Tri clamps

with an outside diameter of 2” and 4” correspond to DIN 32676, but are also useable to ISO 2852. There is no international standard with an outside diameter of 6” for which reason the Adaptor has been standardised based on commonly used dimensions as by the majority of the manufacturers of Tri Clamp -clamping rings -seals and -counter flanges. The following sizes are available:


7.030.1006 Hicoflex® Adaptor 2” (DN 50) 185 mm height



x

± 10 mm

Hicoflex



4.6.4 Hicoflex® Spray Bag

The Hicoflex® Spray Bag is delivered with a spray nozzle suitable for rinsing / wet the

adaptors and connectors inside the charging point. Wetting the contaminated surfaces avoids any potent concentrations of dust to escape when opening the product area.


7.040.1101 Hicoflex® Spray Bag 400 mm height

4.6.5 Hicoflex® Spray Bag with drain

The Hicoflex® Spray Bag with drain has the same specification as the Hicoflex® Spray Bag

but delivered with an additional drain. The outlet enables rinsing/ wet the connectors from below and to drain the waste liquid when i.e. a processor is emptied.


7.040.2101 Hicoflex® Spray Bag with drain 400 mm height

Hicoflex® Spray Bag Hicoflex® Spray Bag with drain

x

± 10 mm x

± 10 mm

40 mm

Hicoflex



4.6.6 Hicoflex® Sample Bag 400

The Hicoflex® Sample Bag is a hose-shaped Hicoflex

® Bag with a sample taker inside. After

docking the Bag, a material sample can be taken without breaking the containment. The approx. volume of sample that can be taken is 5ml. The Hicoflex

® Sample Bag 400 has been developed for taking products from a Hicoflex

®

Charge Bag or a Hicoflex® Charge Bag Plus.


7.050.1101 Hicoflex® Sample Bag 400 400 mm height

4.6.7 Hicoflex® Sample Bag 1200

The Hicoflex® Sample Bag is a hose-shaped Hicoflex

® Bag with a sample taker inside. After

docking the Bag, a material sample can be taken without breaking the containment. The approx. volume of sample that can be taken is 5ml.

The Hicoflex® Sample Bag 1200 is equipped with a flexible lance with a length of approx.

1200mm. This enables taking samples from a more difficult accessible area for example an IBC.


7.055.2101 Hicoflex® Sample Bag 1200 1300 mm height

x

± 10 mm

x

± 10 mm

Sample Bag 400

± 10 mm

Sample Bag 1200

± 10 mm

Hicoflex



4.6.8 Hicoflex® Suction Device

In order to reduce the surface contamination between the couplings, Hicoflex® Suction Device offers the possibility to extract (with air) the airborne particles/dust during dedocking.

This allows to reach a level of <1 g/m3. The Hicoflex® Suction Device can be connected to

the house extraction or a separate vacuum device (available on demand).

Part No. Description

163550 Hicoflex® Suction Device

4.6.9 Hicoflex® Opening Tool Pistol (hand-held)

The Opening Tool Pistol is suitable for hand held manual use, such as when taking samples between a Hicoflex

® Charge Bag and a Hicoflex

® Sample Bag 400.

We recommend to use the hand held opening tool for taking product samples only.

4.6.10 Hicoflex® Opening Tool (fixed installed)

The Hicoflex® Opening Tool shall be mounted on fixed installation. The opening tool is

manually operated for connecting and opening the two couplings.


7.200.1001 Hicoflex® Opening Tool Pistol (hand held)


159028 Hicoflex® Opening Tool (fixed installed)

Hicoflex



4.6.11 Hicoflex® Discharging Station

The Hicoflex® Discharging Station is a framework made out of stainless steel for hanging the bags. The height is adjustable for different sizes of bags. The station does include one manual Hicoflex® opening tool and is available for different Hicoflex® Adaptors as well.


158693 Hicoflex® Discharging Station 2“ (DN 50)



4.6.12 Hicoflex® Charging Station

The Hicoflex® Charging Station is a framework made out of stainless steel with a tray for supporting the bags. The station does include one manual Hicoflex

® Opening Tool and is

available for different Hicoflex®

Adaptors as well.


158696 Hicoflex® Charging Station 2“ (DN 50)



Hicoflex



4.6.13 Hicoflex® Trolley 4”

The Hicoflex® Trolley 4” is a mobile stainless steel frame on wheels with a

Hicoflex®

Adaptor 4” for filling manual the Hicoflex® bags. The Hicoflex

® Trolley 4” does

include one manual Hicoflex®

Opening Tool.


157541 Hicoflex® Trolley 4” (DN 100)

4.7 DOCUMENTATION

All Hicoflex® products are supplied with one set of documentation in English language

consisting of:

- Operating Instructions

- for Hicoflex® consumables: Certificate of Analysis (CoA), certificate of conformity (CoC)

Version: EBO0106201301

hicoflex%20general%20description tcm30 17433

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