Page 9 - Contamination Control
P. 9
GMP Training – Contamination Control in GMP Areas by www.gmpsop.com
GOOD TO KNOW - CONTROL BY CONTAMINATION BY MACHINERY
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.
GOOD TO KNOW - CONTROL OF AIR QUALITY
Contamination can occur if contaminated air comes in direct contact with the
product at the dispensing of starring materials, the formulation of the product,
or the filling of me product into the final product containers. In each case, the
contamination may be airborne particulates, other products or a starting
material of a previous product.
The sources of airborne contamination can be the air supplied to the facility,
operators working in the facility and generating the contaminant, materials
bought into the facility, or machinery used within the facility.
Control of airborne contamination is achieved by controlling the quality of air
within the facility. This relates back to the design of the facility, the air handing
system and the rooms within the facility. The type of air filtration employed
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