Hayden Skalski - SUEZ Water Technologies
Quality Control departments in the pharmaceutical industry often seek new, innovative products to simplify their testing. They want compliant and reliable instruments that are easier for analysts to use and reduce their footprint in the lab. Often, a company wants to change or upgrade to new technology, but they may be reluctant due to the changes that will have to occur.
The Bacterial Endotoxins Test (BET) is a critical release test that every QC lab must perform prior to releasing product, but most methods and instrumentation used today are outdated and cumbersome. When labs want to change methods or upgrade to new BET technology, there are a few steps they will need to assess and complete, a process that is straightforward with the Sievers Eclipse. Each pharmaceutical company is different in terms of its internal procedures, so individual guidelines will also need to be incorporated into the change. The good news is that in terms of LAL testing, the process of changing should be similar throughout the industry. Here are four easy steps to follow when a QC lab wants to change LAL testing methods:
- Establish a validation plan: First, the lab should define what samples and product types they wish to test using the new method or product (e.g., water, raw materials, in process, and/or final drug product). Once products are established, the lab should outline revalidation requirements for each type. For instance, if a lab wishes to revalidate using the Sievers Eclipse from the 96-well plate method for a drug product, they should screen that product at several dilutions up to the Maximum Valid Dilution (MVD) to ensure recovery is acceptable. Once the outline is established and sample types are known, those specific samples can be requested and obtained for revalidation testing.
- Perform method suitability: When it is time to perform method suitability for products, it is important to confirm endotoxin limits and MVDs to ensure the correct dilutions are being made. Once those are known, the inhibition/enhancement screening can begin to determine the best non-interfering dilution to achieve optimum spike recovery, ideally between 75-125%. These results should be documented and reviewed.
- Execute formal validation: Once the dilution is determined for a given product, the lab should execute testing on three discrete lots of each product using that ideal dilution – then document, review, and sign results.
- Document internal procedures: When a product has gone through the validation phase with three lots complete, the lab should create validation reports with the new method/ technique. Once reports are finished and signed, a change control can be implemented per internal Standard Operating Procedures (SOPs) to successfully change product testing to the new method. After the change control is complete, the lab can internally update its LAL testing SOP and procedure with the new method for its products.
Once these four steps have been completed, the QC lab can begin routine testing for products that have been revalidated with the new method/technique. With a well-established plan to revalidate products and samples, the process is not one to be intimidated by. Of course, changes to internal procedures will differ company to company, but in general, changing LAL testing methods is a straightforward process.
Hayden Skalski is the Life Sciences Product Application Specialist for the Sievers Instruments product line, specializing in bacterial endotoxins testing (BET). Hayden has over 8 years of experience in the pharmaceutical industry and Quality Control Microbiology and has presented on numerous topics surrounding endotoxin testing. Previously, Hayden held roles at Charles River Laboratories, Regeneron and Novartis, validating and executing method development protocols for endotoxin testing, providing customer support, troubleshooting and supporting high-volume product testing. Hayden has a B.S. from the University at Albany (SUNY) in Biology.
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