Qualifying Fill Systems For Medical Service

As FDA inches closer to finalizing its Medical Gas Guidance document, we anticipate the introduction of additional requirements that will impact requirements on firms for qualifying a fill system for medical gas use. This article will examine how these FDA requirements are likely to play out in our industry over the coming years.

Compliance-wise, high-pressure filling systems currently fall into two general categories: manual and computer-controlled systems. Computer-controlled high-pressure medical fill systems already must meet a number of additional FDA compliance requirements. These include computer and control system validation, as well as process validation of the fill system. In our opinion, those firms currently using unvalidated or inadequately validated computer operated and controlled high-pressure medical fill systems face a very high risk of an enforcement/seizure action by FDA during a future site inspection.

With the exception of add-on, or portable fill racks, qualification requirements for manually operated high-pressure fill systems are just now coming into FDA’s focus. Portable systems are those that are typically connected to the permanent manifold by means of an extended pigtail, and do not have their own separate control panel. FDA began requiring validation of these systems in the late ’90s, announcing this change in requirements through a number of enforcement actions against major gas firms and independent producers alike. The good news is that these are very easy validations to execute, well within the capability of GAWDA members. Firms currently using unvalidated medical fill racks, in our opinion, also face a high risk of running afoul with FDA in a future inspection. This requirement may partially explain why many firms have moved to upgrade their small medical cylinder filling systems over the last five years.

There are some subtle changes in FDA thinking in the new guidance document, which we believe will start extending validation activities into traditional high-pressure medical cylinder filling systems. For example, our industry has been engaged in a dialogue with FDA on appropriate cylinder vacuum levels. Either as a result of an industry study or by agreement with FDA, a minimum cylinder evacuation level for all medical cylinders will ultimately be established and become part of the cGMP’s. Once this is established, firms will be required to verify and document that all cylinders on a manifold achieve the specified vacuum level during the fill process. The most practical means to accomplish this is to conduct a process validation. Other areas in the FDA guidance document raise similar concerns, such as system cleanliness verifications and check valve (where used) integrity to prevent backflow, adding further impetus towards process validation.

It is interesting to note that the major gas firms and a notable number of the larger independent medical gas manufacturers are already anticipating FDA moving down this road. They have already initiated programs to validate their manual fill systems. As FDA begins to see this trend developing in our industry, validation of high-pressure fill systems will evolve into the current industry practice, or cGMP, further entrenching and extending this requirement into our industry. At this juncture, we see manual fill system validation as an inevitable requirement, but one in which this industry still can have a significant influence in determining the specific compliance requirements.

Validation remains a scary word for many people in our industry, conjuring up visions of complex processes and requirements outside their business capabilities. Many GAWDA members have heard the horror stories about how much time and money the gas majors spent validating their ASU facilities. The good news is that validation of manual fill systems is a much simpler process, and is within the capability of virtually all medical gas manufacturers.

As the GAWDA Medical Gases consultants, we can assist with these key regulatory components and provide guidance on the overall process.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is president & CEO of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at (610) 868-7183 and at bob.yeoman@brcompliance.com.