The construction is finished, the walls are up, the doors hung, the ceiling filters are in place, they are moving in the biosafety cabinets and laminar flow benches, checking the exhaust runs, balancing the airflow in the rooms, things are moving along well toward completion. Now that everything is in place, you start to worry about the next phase: Certification.
- Will it pass? Is it ready?
- Pass what—to what standard should I be compliant?
- Is there more than one standard I need to worry about?
- Once I hook up all the hoods, will I have enough air?
- What pressure differential do I need room to room, or to the hallway?
- Should my rooms be positive or negative?
- Do my people know how to use the different hoods properly?
- How do those hydraulic lifts work anyway?
- If anything goes wrong with the hoods, who do I call? I know all this stuff is new—but is it working correctly?
- Did it all survive shipping and installation?
- Are the filters leaking?
- Am I required to have them checked even though they’re new?
- Is there someone I can get in here to explain all of this?
How many other questions do you have just days before everything is supposed to go live? Who can answer these questions? Or, could these questions have all been dealt with well before this point? Wouldn’t it be nice to have no hanging questions, all issues recognized and dealt with, before the final punch list was done, nothing left but the anticipation of firing up and getting down to business trouble-free, confident in your equipment, room conditions, control of environment, and ability of your systems to maintain proper balance?
Have you ever considered getting your certifier in at the design stage? Why not get the person involved that has years of experience finding, identifying, and fixing the problems that tend to crop up at the worst possible time? You know, someone that can work with your HVAC group to make sure the system has enough reserve static to compensate for HEPA filter loading and the right number of exhaust drops at the right flow rates, and negative pressure at the right place?
The certifier can measure room pressure differential down to four significant digits and calibrate the pressure gauges you have mounted on the wall. He certifies your biosafety cabinets, laminar flow benches, ceiling terminal filters, and modules, and tests the HEPA filters in the AHU (Air Handling Unit), both supply and exhaust.
The certifier is familiar with current Industry Consensus Standards, the ones that apply to your facility, and has them in their computer system, ready to show you and explain what they mean. It’s the same company that OEM manufacturers send in to do their warranty work. The certifier has the specs for the hoods, knows how much exhaust flow is required at what negative pressure range, and knows that those numbers are needed at the point of connection, not up on the roof.
The certifier understands the issues involved when you have building controls (CV boxes, or automated damper controls) fighting the hoods for control of airflow, and how this can affect the internal balance of the hoods themselves. The certifier knows what to tell the HVAC group to do and works with them in order to solve the problem.
Your certification company can work with all groups involved in the project to ensure that your first certification goes without a hitch—on time, on budget, in specification. They can write the IQ/OQ/PQ for you and make sure it’s done correctly. Why wait until everything is installed, final balance is done, systems are running, and everyone is waiting to move in and get busy…only to find all the things that aren’t quite right, aren’t to specification, don’t meet current standards, and need to be remedied ASAP because of time and financial constraints?
An experienced, credentialed certification company can review all this, work with design engineers and equipment installers to make sure it all comes together correctly and is ready for that first test and certification. Credentials should consist of NSF Accreditation for the Biosafety Cabinets, NEBB for the cleanrooms, and backed by a quality system accreditation similar to ISO 9001.
Auditors like to see documentation of training done for the staff on the chemical fume hoods, laminar flow units, and biosafety cabinets—something your certifier can provide—complete with demonstrations on the equipment, using visible smoke sources to illustrate airflow patterns in fume hoods, laminar flow units, and biosafety cabinets, showing good technique, and what’s not good technique.
Certification companies are used to getting called in after the fact, when things are heated and a little stressed—they’d much rather get in early, work to make sure things are coming together right, and make sure your technicians are comfortable using the equipment they have and understand what that equipment can and can’t do.
If you can’t find a manual for a particular piece of equipment, your certification company should have it on hand or be no more than a phone call away from obtaining the information. If you’re having trouble with a piece of equipment, your certifier should be able to contact the manufacturer, tell them what’s wrong, and order the correct parts. Then, as soon as the parts arrive, get them in and get the equipment up and running.
Your certifier can be a valuable source of information gleaned over years of experience. They should be current on all applicable standards, and be able to explain them to you. There is a lot of information in print on room design, proper equipment location, airflow patterns in rooms, and their affect on laminar flow equipment that should be consulted prior to implementing design criteria.
Rick Gastner is National Technical/Safety Manager for ENV Services, Inc., 2880 Bergey Road, Ste. K, Hatfield, PA 19440; 800-883-3681, x1130; rgastner@envservices.com; www.envservices.com
