The manufacture of high quality, well-characterized extracts begins with a comprehensive examination of each product’s overall purity. At ALK we have established quality control methods to ensure that our extracts meet (or exceed) industry standards for identity and safety before they are shipped to our customers.
Identity
The collection of allergen source material is followed by a stringent set of examination criteria to help accurately identify each product. As an additional means of monitoring the lot-to-lot consistency of our source material, certain extracts are periodically selected for an examination of their protein composition using specific biochemical methods (e.g. SDS-PAGE, immunoelectrophoresis, etc.).
Safety
At ALK, safety is always a primary concern. We employ a number of measures during the collection of source material and the manufacture of our extracts in order to minimize any potential health risks. Our manufacturing facilities at ALK also adhere to strict procedures to help assure that our extracts are free from microbial contamination.
- The source water used for extract production is tested daily to measure endotoxin and total organic carbon as required by USP for Water For Injection (WFI).
- Microbial limit testing is performed on all products to assess bioburden content during processing.
- Bottling of extracts is automated and performed under certified class 100 hoods in a class 10,000 clean room.
- All extracts undergo bulk product and final container sterility testing and are quarantined prior to shipping pending the confirmation of a negative sterility test.
- All custom made special mixes and patient treatment vials undergo a 14-day quarantine during which a final sterility assessment is performed.