Preventing Contamination in GMP eBook
Training outcome of the module:
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, molds, spores, yeasts.
Cross-contamination of product is caused by either:
– Contamination of a batch with a previous batch of the same product.
– Contamination with a different product through carryover or proximity of production lines.
– 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 properly maintained.
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.