Airlock System

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AIRLOCK SYSTEM

PREPARED BY:SYED HAMEEZ JAWEDPRODUCTION SUPERVISORINJECTION MANUFACTURING

ABBOTT LABORATORIES


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CONTENTS: What is AirLock System?

Purpose of AirLock System.

FDA Guidence and EU requirements.

AirLock Design.

Pressure Differential.Air Balancing.

Conclusion.


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What Is AirLock System? A room or space designed to act as a mean

of segregating areas of different air

classification or quality. It may contain a method to remove

particulate contamination from clean room aspersonel pass through.

Airlock system is maintain to avoid thechance of cross contamination and toseparate process area.


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PURPOSE OF AIRLOCK SYSTEM: The intention and purpose are the reality of

stable, reliant and compliant operation withina tightly controlled and monitored

environment. In Pharmaceutical, biopharmaceutical and

sterile manufacturing, the clean roomenvironment is the major prerequisite for all

manufacturing activity: without a propermovement mechanism and backgroundenvironment, no medicine can be produce forpatient consumption.


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FDA GUIDENCE AND EU

REQUIREMENTS: FDA guidance for industry states:

Air change rate is another importantclean room design parameter.For class100,000 (ISO 8) airflow sufficient toachieve atleast 20 air changes per hour

is typically acceptable.


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EU requirements:

Adjacent rooms of different gradesshould have a pressure differential of12.5 pascals between classified andnon-classified room.


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AIRLOCK DESIGN: In general, there are three basic airlock

designs that can be combined or usedindividually to protect the clean room and

prevent cross contamination between twoadjacent areas of different process operationsserved by two different HVAC systems. Thesethree airlock systems are:

1: The Cascading pressure Airlock.2:The Pressure Bubble Airlock.3:The Pressure Sink Airlock.


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CASCADING PRESSURE AIRLOCKS: Positive pressure flows from the high

pressure internal zone to be airlock and fromthe airlock to the lesser lower pressure

graded area. Air flows from the clean room to the airlock

and from the airlock to the lower classifiedareas.

Any manufacturing facility where the productrequire protection from particulate but thepeople outside the cleanroom donot needprotection from the product in cleanroom.


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PRESSURE BUBBLE AIRLOCK: A pressure bubble airlock is one with a positive pressure in

relation to the internal and external zone. It runs at positive pressure to both areas therefore it creates a

barrier where contaminants within either areas are pushed back

into their own respective areas. The air being used to pressurize the bubble needs to be of

higher quality than both the internal and externalzone.Conditioned air from a clean non-biocontained source isuse to pressurize the airlock.

Used in areas where product needs protection and the people

external to the clean rooms require protection from the productto reduce the possibility of viable particulate from entering thelesser pressure cleanroom.Area such as compounding area.


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PRESSURE SINK AIRLOCK: A Pressure sink Airlock is one where it runs a

negative pressure in relation to the internaland external zone.

Use to create barrier between the clean roomwhere the process resides and the adjacentareas or area with lower air classification.

By extracting air from the airlocks whenever a

door is open and influx of contaminated airfrom either environment internal and externalenters the airlocks. This contaminated air isdrawn out through appropriate filters.


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POTENT COMPOUND

AIRLOCK: It is a combination of the pressure bubble and

pressure sink airlocks.

This two compartment airlock arrangements allow

personel to protect (gown/respirator) themselvesbefore coming into contact with any dangerousmaterial while at the same time, the product isprotected from contamination from adjacent areas.

All conditioned, clean air supplied to gown room isdissipated into adjacent rooms while all theconditioned clean air supplied to airlock room isexhausted.


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PRESSURE DIFFERENTIAL: In cascading pressure airlock the

differential should be between the clean

room and the non-classified corridor. In both Pressure Bubble and Pressure

sink airlock, it should be between the

airlock and the corridor and betweenthe airlock and the biocontained areas.


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AIR BALANCING: For the Cascade Pressure Airlock, the Pressure Sink Airlock and

the Airlock room portion of the potent compound Airlock, thesupply air minimum CFM must satisfy the clean air classificationair changes per hour. The exhaust/return CFMs are then

adjusted to obtain the required pressure differential. For the Pressure Bubble Airlockand the gown room portion of

the potent compound airlockthe supply CFMs and the exhaustCFMs are temporarily set to the values shown in theconstruction process. The supply CFM is first reduced to obtaindesign pressurization down to the minimum required tomaintain the required air changes per hour. If pressurization isstill low, the return/exhaust CFMs are throttled to increase roompressure upto the design value.


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CONCLUSION: Pharmaceutical industries are meant to

treat diseases and also give immunity to

patients from dangerous diseases. Aproper design must ensure that cleanand sterile products are producedpreventing any re introduction of

bacteria or allergens or any diseasecausing materials into the systems,material and the process.

Airlock System

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