A.L.A. offers a wide variety of laboratory analysis for many different types of sites. We work with sterile compounding facilities, hospitals, pharmacies, and medical manufacturing facilities. The testing done at these facilities is key in the inspection of the environment for bacterial, fungal, and particulate growth. The analysis of these tests will be able to show the facility whether they are meeting guidelines set by other entities, such as USP or the FDA, and even facilities own SOP’s.
Our lab started 15 years ago in a small space created in our building shared with our sister company. Since then we have moved to a new building and created a brand new space that is large enough to handle our work and expanding amount of customers. New equipment and experienced microbiologists have been added to the lab as well.
In order to test for technique and proficiency of a technician’s sterile preparation and procedures, media fill testing is important to complete. Technicians in compounding facilities are required to be skilled in aseptic manipulation. This means that they are consistently able to handle and transfer compounding material without causing any contamination in the process. Consistent media fill testing will ensure that the product was completed aseptically and that the techniques and procedures are being followed correctly to ensure the safety of everyone involved.
We are able to provide both the materials needed for media fill testing and the laboratory analysis that is required after the testing is complete.
This test includes the sampling of personnel throughout the sterile procedures they are completing. Samples can be taken to demonstrate growing proficiency, before and after handling materials to ensure that the protocol is completed correctly and done aseptically. This test ensures that there is not contamination in the product due to a protocol violation.
On top of the laboratory analysis we provide, we can also supply any materials needed for personnel testing.
Our lab has been providing microbial services to the pharmaceutical and medical device industry for over 20 years. We are here to help with any questions concerning sampling procedures, sampling plans, sterility results, and more. In the process of starting a new facility there are many steps that are required to be completed as well as certain results that are expected. A.L.A. knows these guidelines and requirements to help interpret and assist in the completion of the facility validation.