GMP module 04 - Preventing Contamination in GMP

Training Outcome of the Module:

After finishing this module, you will be able to:

  • List the common types of physical and chemical contaminants
  • Describe the consequences of producing contaminated products
  • Identify the potential sources of contamination at your worksite
  • List some ways that you can prevent contamination
  • Potential sources of physical and chemical contamination
  • How your facility has been designed to control contamination?
  • Some practical ways to prevent contamination

 

Part I: What is Contamination

Contamination is the presence of any foreign substance in our products. It may be:

  • Physical: hair, foreign objects, dirt, dust, pollens
  • Chemical: cleaning agents, lubricants, other products
  • Microbiological: bacteria, moulds, spores, yeasts

 

Cross-contamination of product is caused by either:

  • a.contamination of a batch with a previous batch of the same product
  • b.contamination with a different product through carryover or proximity of production lines
  • c.contamination by a foreign starting material usually of the dispensary or in the store

 

The prevention of the cross-contamination requires:

  • the proper sealing, separation and storage of raw materials
  • care in management of the dispensary so as to exclude the opening of different lots of containers in close proximity
  • the thorough and rigorous cleaning of all equipment, utensils, transfer lines, extraction systems and vessels after use
  • re-inspection of equipment before use and line clearances at all stages of manufacture
  • ensuring all air conditioning systems are serviced and property maintained

 

Cleanrooms and cross-contamination

The prevention of cross-contamination is also accomplished by the use of positive air barriers (to exclude other products), dust extractors and containment hoods (to trap and remove dust) during processing. Cleanrooms are specifically designed so the air flow patterns and room pressures protect the product, if is very important to maintain this protection by:

  • Keeping doors closed (to prevent loss of pressure)
  • Keeping air returns clear (to maintain sweeping of air)
  • Cleaning extractors and filters (for efficient operation)
  • Checking room monitors (to verify set pressures)
  • Regularly maintaining/servicing the air handling units

 

Part II: Operation Clean-Up

Incoming goods need to be controlled. Each lot of material must be assigned a unique identification number to ensure traceability and checked for possible transit damage and contamination.

Once these materials are accepted into the facility, they must be stored in such a manner that contamination is minimized. Before use, these materials must be checked for correct identity, cleanliness, integrity of the storage container or protective wrapping and suitability for use in the manufacturing process.

Only by these checks can operators satisfy themselves that the material has not been contaminated during storage end is in fact the right material to be using,

The machinery used in manufacturing a product is an often overlooked source of possible contamination. Possible contaminants are lubricating fluids, wearing parts that generate metal particulates, previous product remaining as a result of incorrect cleaning and malfunctioning equipment that smash containers or have inefficient extraction devices fitted.

The operator using these machines can ensure that contamination of product does not occur by ensuring that the machines are thoroughly cleaned after use and examined for cleanliness before use. During operation, the operator should be constantly aware that a malfunctioning machine may contaminate product and be alert for teaks, drips from lubricating glands or wearing of machine parts.

Machines should be kept in good running order by having periodic preventative maintenance checks performed according to a schedule that relates to the machine age, use, and requirement for servicing. A maintenance program that is directed at breakdown maintenance will not minimize the possibility of contamination of product.

 

Part III: Cleanroom Air Control

Air must be controlled in rooms where product is exposed to the environment. Some important controls for cleanrooms are:

  • Filter the incoming air
  • Control the temperature
  • Control the humidity
  • Have fast flowing air
  • Have a laminar flow
  • Keep the room at a higher pressure than the surrounding areas
  • Keep doors shut!
  • Work areas should be as close to the air inlet as practical since this is where the air will be the cleanest.
  • Air should flow away from the work station and out of the room in a smooth manner.
  • Doors should be kept shut to maintain the air pressure in the room.
  • Do not obstruct the air outlet this will upset the flow of air.
  • Keep the air supply and returns clear of obstructions. This way, you will minimize risk of environmental contamination.

Observe the effects when obstructions are placed in the room, by clicking on the buttons below.

 

Part IV: Cleaning Records

One of the most stated rules in GMP is “You cannot test quality into products. You must build it in at each step in the entire process.” This statement is especially true with regard to effective cleaning and prevention of cross-contamination in products. No amount of laboratory testing can substitute for prevention. The cleaning records, if completed correctly, should verify that each item of equipment in contact with product was cleaned:

  • Using validated written procedures
  • By trained employees
  • Prior to use and stored correctly as per its status tag

 

Conclusion:

Risks of contamination or cross-contamination arise:

  • From starting materials (including water)
  • From the environment and from uncontrolled release of dust, gases, vapors, sprays or organisms from materials or products in process
  • From residues in equipment
  • From operators and their clothing

Contamination control is achieved by:

  • Having well-designed and operated facilities
  • Good housekeeping practices
  • Having written procedures for:
    • handling and storing material and products
    • cleaning of equipment and facilities
    • preventive maintenance programs
    • conducting room and line clearances
  • Having well-trained operators
  • Documenting all deviations or abnormalities

 

Cleanrooms and cross-contamination

Online Quiz:

  • Number of questions: 10
  • No time limit
  • Allow you save and finish at a later date
  • Allow you to go back and change your answer
  • Attempting each question is mandatory
  • Pass mark at and above 70%
  • Print results and certificates
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