Mitigating Personnel Risks

Many pharma companies cite personnel training as the main challenge in maintaining cleanroom conditions. Do you agree with this point?

It is universally accepted that the principle source of cleanroom contamination is personnel. Primary consideration should be focused on reducing personnel interactions as far as possible from any process—and many novel technologies have helped to achieve this. If the use of such technology is not possible, however, the main challenge in maintaining satisfactory cleanroom conditions lies with the training and a culture of correct cleanroom behaviour of personnel.

A primary change area within the facility ensures that outside garments are removed and cleanroom undergarments are used prior to entry to a separate cleanroom gowning change area. At our company, access to both these areas is restricted by means of biometric control, which provides added protection against unauthorised entry. Contamination risks are mitigated through a number of different training programmes, a proven changing regime, restricted access and a deep-seated culture of the importance of contamination control and the potential consequences of control deficiency.

What training programmes do you have in place for new cleanroom personnel?

All personnel who require access to cleanrooms to perform their job undergo both an induction and cGMP training upon recruitment. All cleanroom operators also undergo specific training that focuses on cleanroom behaviour, as well as training sessions within the microbiology laboratory. This provides theoretical and practical exposure to microbiology and enables first-hand experience of the sources and types of potential microbiological contamination. In addition, operators involved in aseptic processing undergo specific training relevant to each process and the equipment used.

How do you ensure that standards and best practices continue to be met by personnel after training is completed?

Upon completion of the initial training, we issue a cleanroom operator entry license, which is renewed on an annual basis following a reassessment to ensure satisfactory standards are achieved in cleanroom entry and gowning. Cleanroom behaviour is continually monitored by production supervision and periodically through quality audit. Process Simulation Trials (PST) are conducted on a regular basis and a comprehensive system for aseptic operator licensing is employed where licenses are only issued following an assessment of an individual’s performance during a PST.

Over the years, are there any common, personnel-related issues or mistakes that you’ve seen time and again?

A simple and logical facility layout and changing regime provides for consistent maintenance of satisfactory cleanroom conditions. In our company, there is a strong culture of peer monitoring and awareness so fortunately we haven’t observed any common personnel-related issues. However, we do have a comprehensive environmental monitoring system that has enabled the development of a wild-type database, providing valuable information regarding microbiological population trends within the facility. The results and any adverse trends can be used to target specific areas for attention either with respect to cleaning or process modifications or improvements.

Some experts claim that activities conducted prior to entering the workplace can affect contamination levels within a sterile environment. How can risks like this be controlled?

There is an ongoing debate about this issue and, arguably, there is a risk that activities outside the workplace have the potential to influence cleanroom conditions. Specific risks can be controlled through the use of specific criteria for cleanroom entry. Where there is a risk of adventitious viral or prion contamination to a downstream process that has undergone viral clearance or filtration, then strict entry requirements, changing regime and movement through the facility can successfully be employed. Where there is a risk of bacterial contamination to an aseptic process, isolator technology is the most effective way of mitigating this risk.

Neal Wesley is technical director at SCM Pharma. http://www.scmpharma.com