Page 3 - Contamination Control

GMP Training – Contamination Control in GMP Areas by www.gmpsop.com

GOOD TO KNOW - CROSS-CONTAMINATION
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:
a. the proper sealing, separation and storage of raw materials
b. care in management of the dispensary so as to exclude the opening of
different lots of containers in close proximity
c. the thorough and rigorous cleaning of all equipment, utensils, transfer lines,
extraction systems and vessels after use

d. re-inspection of equipment before use and line clearances at all stages of
manufacture
e. 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

Main sources of contamination

Environment in which the product is formulated and filled

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