The majority of contamination in a pharmaceutical facility, presuming that the air handling system is functioning as designed, that water systems are low in bioburden and are not leaking, and there is good control of in-coming materials, will derive from people. It follows that an effective contamination control strategy will focus on the control of operators. Control extends to behaviors, gowning and having the correct equipment, and this will be supported by periodic qualifications and underpinned by audits. These requirements are spelt out in EU GMP Annex1, which states1: “The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure.” And the FDA guidance for sterile product manufacture2: “As operator activities increase in an aseptic processing operation, the risk to finished product sterility also increases. To ensure maintenance of product sterility, it is critical for operators involved in aseptic activities to use aseptic technique at all times” (my emphasis). The traditional model of environmental control and environmental monitoring is a reactive one. Incidents happen, trends are assessed, microorganisms are identified and (ideally) effective corrective and preventive actions are set. While this model will always need to exist, it is far better to focus on preventative strategies to reduce microbial contamination. Given the association between microbial contamination in the cleanroom and people, the most useful preventive strategy involves improving controls around personnel. This article addresses some of the key concerns relating to operators within cleanrooms, in the context of the risk operators pose in terms of microbial contamination. The article is divided into three sections. The first part looks at means to improve operator behaviors, the second part looks at how regular reviews by plant microbiologists or quality assurance staff can help to reinforce these behaviors, and the third part considers the idea of having ‘environmental control champions’ within the production facility.

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• Contamination Control

• Facilities

• Environmental Control

• Environmental Efficiency

• Personnel

• Training

• American Pharmaceutical Review

• 4/30/2019

• Article