Biomedical Engineering Reference
In-Depth Information
Agents, if any, used to help equipment operate more smoothly or efficiently,
such as lubricants, should be part of the risk assessment to determine their
proper selection and use including the safeguards required to avoid their coming
in contact with the product or product packaging components. Lubricants that
are appropriate for pharmaceutical use and safe for the environment should be
selected. The methods used to dispense them should avoid their being expelled
into the environment (e.g., sprays) or coming in contact with surfaces that could
lead to product contamination.
11.2.5.4 Validation A crucial control component of any process is validation.
Once the proper critical steps are identified and it has been determined that these
steps are properly controlled, the processes are validated. Validation activities
are designed to provide data that confirms that the chosen parameters deliver the
product as intended. The question is not whether or not to validate but whether
or not the validation activities are adequate for confirmation.
11.2.6 People
Risk associated with personnel should be considered in either of two ways:
1. The risk to product quality resulting from microbial and other particulate
contamination from personnel.
2. The risk to personnel who may be exposed to harmful materials during the
manufacturing process.
Personnel have been credited with contributing the greatest risk particulate
and microbial product contamination [18]. They routinely shed non-viable par-
ticulate from skin and hair and naturally harbor microorganisms as part of their
biological makeup on their skin and in their nose and throat. To reduce the risk of
introducing these contaminants to the product, it is important to assess whether
or not adequate controls are in place.
11.2.6.1 Personal Hygiene Starting with the basics, personnel should
be required to practice good personal hygiene. Depending on the level of
control required, it may be necessary that personnel shower before entry to a
manufacturing area or in the case of exposure to harmful materials, afterwards.
Written procedures should instruct personnel on the proper cautionary measures
to take when sick, sneezing, or coughing in the workplace to avoid the risk of
contaminating the environment and product.
11.2.6.2 Protective Clothing and Gear Protective clothing or gear is a major
player in both minimizing the introduction of contamination and minimizing
personnel exposure to harmful materials. Protective clothing acts as a barrier
between a person and the surrounding environment. In one role, its purpose is
to contain particulate that would otherwise normally be shed by personnel. In
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