Personnel

A well-designed, maintained, and operated aseptic process minimizes personnel intervention. 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.

Appropriate training should be conducted before an individual is permitted to enter the aseptic manufacturing area. Fundamental training topics should include aseptic technique, cleanroom behavior, microbiology, hygiene, gowning, patient safety hazards posed by a nonsterile drug product, and the specific written procedures covering aseptic manufacturing area operations. After initial training, personnel should participate regularly in an ongoing training program. Supervisory personnel should routinely evaluate each operator's conformance to written procedures during actual operations. Similarly, the quality control unit should provide regular oversight of adherence to established, written procedures and aseptic technique during manufacturing operations.

EU Annex 1 WHO GMP PICS

Some of the techniques aimed at maintaining sterility of sterile items and surfaces include:

Contact sterile materials only with sterile instruments. Sterile instruments should always be used in the handling of sterilized materials. Between uses, sterile instruments should be held under Class 100 (ISO 5) conditions and maintained in a manner that prevents contamination (e.g., placed in sterilized containers). Instruments should be replaced as necessary throughout an operation.

After initial gowning, sterile gloves should be regularly sanitized or changed, as appropriate, to minimize the risk of contamination. Personnel should not directly contact sterile products, containers, closures, or critical surfaces with any part of their gown or gloves.

Move slowly and deliberately.

Rapid movements can create unacceptable turbulence in a critical area. Such movements disrupt the unidirectional airflow, presenting a challenge beyond intended cleanroom design and control parameters. The principle of slow, careful movement should be followed throughout the cleanroom.

Keep the entire body out of the path of unidirectional airflow.

Unidirectional airflow design is used to protect sterile equipment surfaces, container- closures, and product. Disruption of the path of unidirectional flow air in the critical area can pose a risk to product sterility.

Approach a necessary manipulation in a manner that does not compromise sterility of the product.

To maintain sterility of nearby sterile materials, a proper aseptic manipulation should be approached from the side and not above the product (in vertical unidirectional flow operations). Also, operators should refrain from speaking when in direct proximity to the critical area.

Maintain Proper Gown Control. Prior to and throughout aseptic operations, an operator should not engage in any activity that poses an unreasonable contamination risk to the gown.

Paragraph 37

All personnel (including those concerned with cleaning and maintenance) employed in such areas should receive regular training in disciplines relevant to the correct manufacture of sterile products. This training should include reference to hygiene and to the basic elements of microbiology. When outside staff who have not received such training (e.g. building or maintenance contractors) need to be brought in, particular care should be taken over their instruction and supervision.

Paragraph 40

Wristwatches, make-up and jewelry should not be worn in clean areas.

Paragraph 10.2

All personnel (including those concerned with cleaning and maintenance) employed in such areas should receive initial and regular training in disciplines relevant to the correct manufacture of sterile products, including hygiene and the basic elements of microbiology. When outside staff who have not received such training (e.g. building or maintenance contractors) need to be brought in, particular care should be taken over their instruction and supervision.

Paragraph 10.4

High standards of personal hygiene and cleanliness are essential and personnel involved in the manufacture of sterile preparations should be instructed to report any conditions that may cause the shedding of abnormal numbers or types of contaminants; periodic health checks for such conditions are desirable. The action to be taken in respect of personnel who might be introducing undue microbial hazards should be decided by a designated competent person.

Paragraph 10.7

Wrist-watches, cosmetics and jewellery should not be worn in clean areas.

Paragraph 8.3

A formal personnel training program is needed for all activities in each clean room. This means the program has to be planned, documented and repeated at adequate intervals to ensure that the once trained individual meets the ongoing requirements for the work in a controlled environment.