associated pipework will ensure there are no dead legs where water can build up
and stagnate causing microbiological issues.
Drains and wash bays can also pose a significant risk and provide an
ideal environment for bacteria to multiply, they are usually the areas of
highest contamination and should be suitably placed.
can be a major contributor of potential microbial ingress to the product. The potential exists therefore for personnel
to contaminate the product with the organisms residing on his or her body. This contamination may be direct, with
personnel coming into direct contact with the product or indirect by
contamination via particles of skin, hair and clothing generated from the body
into the air. The potential for
contamination of product by personnel can be reduced by use of closed product
systems. Closed manufacturing systems,
closed vessels and piped transfers severely reduce the potential for microbial
contamination from personnel. Personal
Hygiene is perhaps the single most important means of reducing the potential
for product contamination by personnel.
Poor attention to hygiene can lead to a dramatic increase in microbial
numbers on the body and can also lead to colonisation with potential
pathogens. Failure to wash hands for
instance after visiting the toilet a lead to contamination with organisms such
as E. coli (Escherichia coli), other coliforms and streptococci. Appropriate training in the importance of
personal hygiene should be given and facilities provided to maintain acceptable
levels of cleanliness. 21 CFR 211.25(a) states that ‘Each
person engaged in the manufacture, processing, packing or holding of a drug
product shall have education, training and experience or any combination
thereof, to enable that person to perform the assigned functions’. * The
appropriate training should be conducted before an individual is permitted to
enter the manufacturing area. Personnel
should be trained in the operation in which they are performing, and duties
should be conducted within cGMP (current Good Manufacturing Practices).