© all rights reserved by fette gmbh, also in case of pending patens. all uses, e.g. like copying or...

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© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us. FETTE ABSOLUT Filter system For production processes in chemical and pharmaceutical industries

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Page 1: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

FETTE ABSOLUT Filter systemFETTE ABSOLUT Filter system

For production processes in chemical and pharmaceutical industries

Page 2: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Reason for development ofnew containment technologiesReason for development ofnew containment technologies

The rise of the usage of potent compounds within the pharma industry worldwide

The awareness of the dangers created by cross contamination and personnel safety

The general industrial dust filters applied in the pharmaceutical industry today

Result:Creating the missing link to meet the latest requirements in hygienic pharmaceutical production processes

Page 3: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Disassembly Conventional HEPA filter units manufactured for the nuclear industry

Highest possible requirements in regard to: Efficiencies

Containment

Origin of the new filter system for production linesOrigin of the new filter system for production lines

For manual handling of hazardous products in chemical and pharmaceutical industry

Page 4: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Laminar Flow Ceilings Personnel

Floodgate

FETTE Absolut fields of productionFETTE Absolut fields of production

Dust Filtration

Glove-Boxes

Isolators

Gasab-sobtion

Ventilation

Page 5: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Product overviewProduct overview

To protect the product

size and version according requirements

Recirculation series /   ventilation series

• Horizontal series • Vertical series

Machine room:•Basic •Standard Pharmaceutical production room areas:•Pharma •GMP

Positive pressure isolators

Personnel floodgateUnit series

Residual dust load0,0001mg/m³

Air capacity300 - 64.000 m³/unit

Residual dust load0,0001mg/m³

Air capacity300 – 33.000 m³/h/unit

Two stage HEPA filter unit non dedustabel

Two stage dedustable HEPA filter unit

To protect personnel and production rooms/size and version according requirements

Size and construction according requirements

Efficiency Acc. specificationAir capacity300 – 16.000 m³/h/unit

Residual dust load0,1 - 0,0001mg/m³

Air capacity300 – 64.000 m³/unit

Residual dust load0,1 mg/ m³

Air capacity300 – 33.000 m³/h/unit

Negative pressure isolators

Laminar Flow CeilingsCassette-constructionSingle stage HEPA filterunits non dedustable

Single stage dedustable HEPA filter units

Glove-Boxes/Isolators

Laminar Flow Ceilings / Personnel Floodgate

GasadsorbtionVentilationDust filtration

Page 6: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Dust filtration and recovery of high dust loads from production machines such as:

Fluid bed dryers

Tablet presses

Capsule filling machines

Tablet coaters

Tablet filling machines etc.

Application of the new filter systemApplication of the new filter system

Page 7: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

General surveyGeneral survey

GMP series for production rooms

Single module unit

Application : Dust recovery from tablet presses

Features:

2 stage HEPA filter unit

Integrated glove box

Scanning device

Page 8: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

GMP series for production rooms

Multiple module unit

Application : Dust recovery from tablet presses

Features:

2 stage HEPA filter unit

Integrated glove box

Tablet for filter stage

General surveyGeneral survey

Page 9: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Standard series for machine rooms

Single module unit

Application : Dust recovery from tablet presses

Features:

2 stage HEPA filter unit

Reinforced body for application in explosion areas

General surveyGeneral survey

Page 10: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

DOPDOP

Measuring of efficiency

Typical Laser-Particle Counter

Page 11: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Take away the servicing door

Filter ChangeFilter Change

Pull out the inner plastic bag, which is always part of the unit

Lower the sealed filter cassette for take out

1 2 3

Page 12: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Pull the cassette out into the existing plastic bag

Filter ChangeFilter Change

Heat sealing of the cassette twice to cut the bag in between

In the end the used and sealed filter cassette is ready for disposal

4 5 6

Page 13: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

The Operator pulls the can to the front, in order to seal it, inside the isolator

Dust recoveryDust recovery

He puts a lid onto the inner plastic bag

1 2

Page 14: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

The operator puts the can to the side in order to pull the closed inner bag out

Dust recoveryDust recovery

3 4

As a further step he pulls the inner bag out through a LaCalhene valve into the outer bag

Page 15: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

The door is closed from inside to be able to undock the alpha port (outer port)

Dust recoveryDust recovery

The outer alpha port is being undocked by turning

The double sealed product now is ready for take away in a safest possible way

5 6 7

Page 16: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

Weighing of recovered productWeighing of recovered product

The operator, according to the efficiency measurement of the cassettes, gets a printout for documentation of the recovered product

Page 17: © All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to

© All rights reserved by Fette GmbH, also in case of pending patens. All uses, e.g. like copying or disclosure to third parties, strictly restricted to us.

TargetsTargets

Our targets are to close the gap in hygienic pharmaceutical production processes by providing:

Lowest possible

OELs

Highest possible

filter efficiencies