The United States accounts for roughly half of the global pharmaceutical market. This certainly keeps the Food and Drug Administration (FDA) busy in its oversight of pharmaceutical safety and effectiveness, including with the production processes. As the pharmaceutical industry has grown, so too has its utilization of compressed air for breathing air, operation of equipment and instrument air.
The FDA has taken notice, of course, and the quality of the air being used is a concern; and, rightly so, no standard has been issued for the use of compressed air in production.
“A one-size-fits-all standard won’t work here,” says Dr. Ed Golla, Laboratory Director for Austin, Texas-based TRI Air Testing. “Everyone is doing something a little different.”
While this leaves pharmaceutical companies a somewhat in the dark as to how to vet and confirm the quality of air being used, it does not mean companies need to find the tightest standard possible. Each facility will have unique needs, and the standard applied should best serve these needs.
UNDERSTANDING YOUR FACILITY
In the absence of specified standards governing compressed air quality testing in the manufacturing process or production of pharmaceutical, medical device, and food applications, it is often best to use composite, site-specific testing programs. This may be the most assured way to produce valid, repeatable testing results that will reinforce your site’s quality. Direct Product Contact, Indirect Product Contact, USP and ISO 8573 air standards are common sources from which to draw. A routine testing schedule for your compressed air quality program should provide the appropriate verification and compliance each facility will need for OSHA, FDA and cGMP.
It is imperative that you understand the real needs of each site. You do not need to expend the time and money to establish a quality of air that you don’t actually need. “Clean room” air in a non-clean room air operation, for example, is unnecessary. Specifying air to that level requires expensive equipment to clean and maintain it.
If you bring clean room-level air into a non-clean room environment the quality of the clean air is decreased to the level of the room environment. You’ve brought a small amount of clean air into a larger volume of air at a lower level.
“What they really need to do,” says Dr. Golla, “is first look at the quality of air as it is now--as you’ve been using it for the last 10 or 15 years. Identify that quality and base your spec on the quality of air you have input from the engineers involved in the actual process you’re using.”
Greater operational efficiency in air management and cost control can be found in understanding the true air needs in each area of your facility rather than using a single approach for the whole facility.
TRI Air Testing works with many pharmaceutical companies in helping them assess and identify the right air quality tests for compliance, operational efficiency, and safety. TRI sends out its testing equipment along with appropriate sampling media. Clients return the samples for analysis and reports are available within 24 hours.
“The depth and stringency of ISO 8573 may be perfectly applicable to an operation’s clean room particulate control,” says Dr. Golla, “but it isn’t right for all applications.”
Facilities with clean room needs, such as those handling implantable devises (e.g., knee and hip joints, defibrillators and pacemakers) cannot have particulate matter on their surface and affecting the safety of product. These facilities must utilize a spec that ensures a heightened level of particle control.
“You can’t use a spec allowing 5 mg per cubic meter or 1 mg per cubic meter or even a 0.1 mg per cubic meter,” says Dr. Golla. “You need information about the individual particle sizes and counts. With implantable devises once you clean the surface and blow it with compressed air you don’t want to leave particles on it.”
The ISO 8573 spec Class 1 or Class 2 requirements may be ideal here.
But for operations that might be using compressed air to blow out bottles before putting in tablets or simply running a piece of machinery, that most stringent air standard may be excessive. It may lead to greater operational expense or present the facility with a test that is difficult, if not impossible to pass—and all on a process that does not actually need that high of a quality of air.
“If they are concerned about particles, but do not necessarily need something like 8573 Class 1 or Class 2,” says Dr. Golla, “they can use a point-of-use filter.”
If only 1% of a facility, for example, uses a very high-quality air for a specific application, but the general air use in the rest of the facility does not need that quality of air, a point-of-use filter may be the right solution and help achieve greater operational efficiency.
One recommendation: engage the production engineers who are most familiar with the air quality needs. Ask them if there is anything that shouldn’t be in the air. Does it need to be filtered to a finer level? Does the air need to be moist? Or does it need to be dry?
Understanding the real impact of air quality on the specific zone of work, the people conducting the work, and the product being produced or serviced will go a long way towards guaranteeing compliance, levels of safety and the quality the FDA and other regulatory entities want to see.
THE CHALLENGE OF MOISTURE
Identifying a proper moisture spec is not easy. Many facilities just use refrigerated air. They cool the air to remove water; then, they bring it back to room temperature so the humidity is relatively low and you won’t get water formation and bacteria growth.
“That’s probably what you need in 90% or more of the operations,” Dr. Golla says, “yet, we put out a guideline to say there ought to be at least a -10°F for indirect product contact and -50°F or so for direct product contact. I think we put a pretty big asterisk on that to recognize that this one may or may not apply.”
Certain products will be destroyed by -50°F degree dew point air. It will desiccate and deactivate them. For other products, the moisture could react with the material and cause problems, so you might need extremely dry air.
Just as ISO 8573’s most stringent requirement classes are not right for all particulate testing of compressed air, there is no single approach to dew point and moisture management.