What is the difference between a laboratory GLP and GMP steam sterilizer?

GMP sterilizer

Typically, any product used for testing or manufacturing a drug product for human use will need to be sterilized in a GMP autoclave, or the drug product itself will be terminally sterilized. GMP steam sterilizers need to comply with a stringent set of requirements, ranging from approved construction materials to the purity of the water that can be fed into the sterilizer. For more specific information on these requirements, please refer to the table at the bottom of the page.

Non-GMP sterilizer

Non-GMP sterilizers fall into two categories: basic laboratory research and good laboratory practice (GLP). Sterilizers belonging to these two types are much less expensive to purchase and maintain than GMP sterilizers, and can be customized to a greater degree for their intended application. The vast majority of sterilization performed in pharmaceutical or biotech facilities exceeds GMP requirements. Here are some examples of non-GMP sterilizer applications:

Waste is sterilized before disposal

Sterilize products that are used for laboratory or R&D purposes and do not support production areas

Sterilization of products tested for animal and other non-human use

For these products, non-GMP sterilizers can provide the same service at a fraction of the upfront and operating costs.

GLP sterilizer

GLP is a secondary designation that relaxes certain GMP regulatory requirements for preclinical trials. If you know your research will eventually lead to a clinical trial and want an autoclave that can be used from the discovery phase to the pre-clinical stage without the ongoing regulation of GMP then a GLP sterilizer is a good choice . GLP sterilizers can be a lower cost alternative and only need to be replaced if the laboratory needs to increase production/clinical trial base. Due to reduced requirements, most laboratory sterilizer manufacturers can meet GLP standards (listed in the table below) with the correct combination of optional features.

laboratory sterilizer

Laboratory sterilizers are commonly used in universities as well as in biotechnology, animal and life sciences, pharmaceutical, food, industrial or biosafety laboratory level 3 applications.

For better cost reduction, laboratory sterilizers should be used for all applications that do not require GMP. Even if the main use of the company's products is pharmaceuticals, red bag waste, products used for research and animal testing, and all packaging that does not come into direct contact with products for human use can be sterilized in a non-GMP laboratory sterilizer. Before purchasing an autoclave, please conduct an effective analysis of the application of the autoclave and determine whether GMP sterilization is required.