5.4 Protective Clothing
clothing and strict gowning procedures can reduce or minimise the release of
particles from personnel into the production environment. Depending upon the quality requirements of
the product and the potential for contamination, appropriate clothing should be
provided, this may be freshly laundered trousers and shirts with mob cap to
contain hair, gloves and masks. In
aseptic manufacture staff are required to wear all enveloping gowns, over
boots, hoods, gloves and masks which have been sterilised and prepared from
non-shedding materials. PICS guide, Annex 1 states, clause 42 states ‘The
clothing and its quality should be appropriate for the process and grade of the
working area. It should be worn in such
a way as to protect the product from contamination’. * Operators should
receive effective training on the importance of gown-up procedures and should receive
regular training in disciplines relevant to the correct manufacture of products.
A fundamental part of any manufacturing facility is cleaning
and disinfection. Inadequate cleaning will
have a direct impact on product quality.
Selecting suitable disinfectants that demonstrate the required level of
efficacy and cleaning techniques and procedures are issues to consider. It does not matter how efficient the disinfectant
is, if the cleaning technique and procedure are poor then cleaning is not
effective. Detergents are primarily used
to remove dirt, grease and previous disinfectant residue as failure to do so
can provide nutrition and an ideal environment for microorganisms to flourish. Dirt can also interfere with the action of
the disinfectants and render them ineffective.
Disinfectants are chemical or physical agents to destroy or inhibit the
activity of microorganisms although not all spores are killed. Bacterial spores are among the most resistant
of all living cells. Sporicidal
disinfectants can be used and will kill spore formers. It is probable that two or more disinfectants
should be used, there should be a planned rotation of cleaning solutions to
avoid resistance to cleaning methods and disinfectants.