Do I Need a GLP or GMP Autoclave?
By: Priorclave North America
Category: Lab Design
Customers often ask us: “Do I Need a GLP or GMP Autoclave?”
Usually, the answer is “No, you don’t.” That’s because, in the grand scheme of things, only a narrow band of lab activities require GLP/GMP. The vast majority of sterilization tasks fall outside of the scope of these quality systems. In fact, even facilities doing work that calls for strict adherence to GLP or GMP usually have both a standard lab autoclave and a so-called “FDA-approved” autoclave.
Why Would I Need a GLP or GMP Autoclave?
GMP and GLP are quality systems. The guiding principle behind all GMPs/GLPs is simple:
“Protect humans from being harmed by products.”
Regulatory agencies create GMPs/GLPs so that individuals and organizations can be confident that products are safe for human consumption or use.
So, in general, if you are sterilizing something that’s going to go into a live human or animal then you likely need either a GMP or GLP sterilizer. (Examples of such items include medical devices in production, surgical instruments, or batches of medicine heading to market.)
Otherwise, a research-grade lab autoclave is probably preferable.
What Are GMP, cGMP, and GLP?
“GMP” stands for “good manufacturing practices”. It’s a quality system for the manufacturing of products intended for human use. (E.g., food/beverage, cosmetics, pharmaceuticals, dietary supplements, and medical devices.)
GMPs are enforced by different agencies in different places. For example, in the U.S., the Food and Drug Administration (FDA) enforces GMPs. (It refers to these as “current good manufacturing practices,” hence cGMP). Globally, the World Health Organization (WHO) enforces GMPs in much of the developing world. The European Medicines Agency does so in Europe. Regardless of region, these GMPs are similar—or even identical. (Pharmaceutical GMPs, for example, are almost identical globally.)
Whatever the region or product, the goals of GMPs are always the same:
Prevent people being harmed by food, medicine, or medical devices that are contaminated, inconsistent from batch to batch, manufactured under poorly controlled conditions, or not consistently checked for quality throughout the manufacturing process.
GLP, or “good laboratory practices,” are similar to GMP. GLP aims to protect health and safety by ensuring the “uniformity, consistency, reliability, reproducibility, quality, and integrity” of research into producing products for human or animal use. The same agencies that enforce GMP for a region often enforce GLP as well. (For example, in the US, the FDA oversees both GLP and GMP. In the EU the European Medicines Agency handles the coordination of both GLP and GMP oversight in member nations.) The primary difference between GMPs and GLPs—as the names imply—is that GMPs apply to manufacturing whole GLPs apply to laboratory research.
Importantly, GLPs apply only to a narrow category of lab research. Non-clinical safety/efficacy studies for products (especially pharmaceuticals) intended for use in people, animals, or the environment generally require GLP compliance. Other research—even some exploratory/feasibility research that will result in a product intended for animal or human use—does not require GLP compliance.
What Are “GMP” and “GLP” Autoclaves?
Neither GMPs nor GLPs specifically mandate what is or is not a “GMP autoclave” or “GLP autoclave”. They instead speak, in detail, to operating procedures, working conditions, data tracking/documentation practices, and expectations of cleanliness and sterility. That, in turn, implies certain features for various pieces of equipment.
For example, US FDA GLP rules require:
“All raw data, documentation, protocols, final reports, and specimens … generated as a result of a nonclinical laboratory study shall be retained. There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports.”
The rules do not stipulate your autoclave must have a control system that integrates data logging and archiving. But it’s clearly a feature you want. Some manufacturers even highlight that their control systems feature “GLP-compatible data management” or produce “GLP-compatible documentation”. That can be as simple as spitting out a printed receipt after each cycle or simply logging them to internal memory.
As a practical matter, most “GMP/GLP” autoclaves have medical-grade stainless steel plumbing, a 316L stainless steel pressure vessel, and exhaust filtration for all air and steam leaving the chamber. Depending on your application and region, meeting GMP/GLP expectations might also require high-purity water supply, a dry steam supply, a specific finish on exposed steel parts, third-party IQ/OQ/PQ documentation, etc.
In some cases, a governing body (like the FDA) will pre-approve a device as being appropriate to a given GLP or GMP application. Such a sterilizer might be marketed as “FDA-approved” or “510(k) exempt“—and tend to be priced accordingly.
Considerations for Choosing Quality Control Laboratory Equipment
Before purchasing an autoclave, first think through all of the applications where you’ll use that autoclave. Next determine whether any of them call for GMP/GLP sterilization. What are the specifics of the cGMP or GLP for your region and scenario?
For example, under certain cGMPs, tap water is fine for steam generation. In those cases, standard autoclave plumbing configurations are appropriate. But some cGMPs require the use of ultra pure water. In these cases, the manufacturer will need to supply all stainless steel pipes and fittings to enable customers to comply with their protocols. Still other cGMPs require “crevice free polish” on all plumbing and tri-clover type connections (also called “sanitary fittings”). Similarly, while most GLPs simply require good record keeping and archiving of sterilization cycles, there are cGMPs that demand that certain temperature monitoring and control devices function independently of each other.
Making your autoclave manufacturer aware of these expectations assures they can build an autoclave that enables you to meet your cGMP/GLP.
Unsurprisingly, additions, modifications, and upgrades—all steel plumbing, independent drain temperature monitoring probes, and so on—quickly add up. Given the high price of any piece of “FDA-approved” equipment, it’s not unusual to see GMP/GLP facilities that have both a GMP/GLP autoclave and a standard lab autoclave. Red bag waste, products for research and animal testing, and all packaging that does not directly contact a human-use product can be sterilized in non-GMP laboratory sterilizers. That’s the case even if the primary application of the company’s product is pharmaceutical.
This isn’t jus a cost-saving measure. In the interest of preventing cross-contamination, some international GLP and GMP auditors urge labs to always have a separate autoclave used solely for red bag waste.