by David S. Phillips and Richard Gastner, ENV Services
What’s the last thing on the schedule prior to start-up of a new cleanroom or controlled environment? It’s normally the one thing given the least weight in the grand scheme of things; the one thing added almost as an afterthought; the one thing that can often be the source of a lot of last-minute cost overruns and time crunches. Give up? How about the final certification? The one thing that provides the go-ahead documentation that the environment meets all the applicable project and industry criteria.
How easy would it be to avoid the “normal” problems and issues that can plague that critical, final item on the punch list? Certification groups are an invaluable source of information, planning and design input that can lead to the on-time, on-budget and on-target start-up of a new or renovated cleanroom.
There has been much in print recently involving coordinating the efforts of the design engineers and the contractors actually building the project. Communication between the two groups is critical. So why aren’t the certification groups included in that process? The efforts of the first two groups have to come together to meet a lot of industry standards and regulatory requirements that they end up leaving to those “other guys.”
Unfortunately, those other guys are all too often brought in at the last minute under a lot of pressure to “make it work.” In the wings await the auditors and regulatory inspectors, and the in-house validation group. Feeling the pressure?
It doesn’t have to be like that. All it takes is involving your certification group in the design and planning stages. Coordinate with them, and let them know what you need and what you want. They can take it from there. The design engineers and contractors have to know and understand what the certifiers need engineered into the design plan to enable them to perform a thorough and legitimate certification. And not just for that first time, but for every annual or semiannual certification thereafter.
The final certification should not be a hurdle but a verification of the environment’s ability to meet and maintain conditions in accordance with all applicable project, industry and regulatory requirements. To accomplish this, we propose the following idea: Project managers should issue a Request for Proposal (RFP) to certification groups.
The RFP should require certain elements, among them a detailed Certification Approach Plan, with all details supported by appropriate citations of the current industry standards. This should include the design and engineering details needed to ensure the ability of the certifier to perform a certification to all appropriate requirements.
Good, credentialed certifiers will analyze the planned zones, the contamination-control concepts and the anticipated processes and equipment in each zone. From this analysis should come one or more certification approaches. These approaches should identify key cost elements, required test equipment, measurements, accuracies, and the analysis and acceptance criteria. A good approach should contain a template for the RFP.
The idea here is to make the planning for the certification an integral part of the overall design and plan for the environment. This ensures that final certification is as efficient and cost-effective as possible. The cost of the certification approach plan will be recovered in the savings realized by the absence of major problems, certification delays or last-minute changes in design or implementation.
Certifiers really don’t like to walk into a new facility, with all eyes on them, and realize that there are major obstacles to accomplishing a timely, accurate and legitimate certification of the environment. They’d much rather get in, do the job, document the results and issue the appropriate certificates of compliance to get the facility up and running and keep their clients satisfied with their efforts. Besides, customers really don’t like to hear their certifiers use the words, “We have a problem…”
David S. Phillips has been with ENV Services since 1981. Prior to assuming his current role as technical manager, he served in various national and regional roles for ENV Services including general manager, director of operations, director of technical support, Midwest region manager, NIH contract supervisor, and field service technician. He can be reached via e-mail at [email protected]
Richard Gastner handles technical support of ENV’s nationwide field personnel for biomedical equipment services. He has been with ENV Services since 1985. He has a Bachelor’s degree in business administration from Villanova University, and is an NSF-accredited Biohazard Cabinet Field Certifier. He can be reached via e-mail at [email protected]