Services
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.
Environmental Monitoring Analysis
- Environmental monitoring is a tool used in the pharmaceutical and medical device manufacturing facilities and is completed through air and surface sampling.
- Analyzing the samples allows the lab to identify bacterial and fungal growth that is present.
- Qualitative and quantitative analysis is available and further species identification can be performed upon request.
USP 797 Analysis
- To ensure the sterility requirments of cleanrooms impaction air sampling and surface sampling is necessary.
- If colonies are present after incubation, analysis and isolate identification is required to better understand the cause and source of the growth in the environment.
- For USP cleanrooms, both single plate and dual plate methods of sampling are acceptable.
Bacterial Qualitative Analysis
- Bacterial isolate, genus, and species identification is available.
- These tests allow the identification of the species that is present and therefore can lead to a better understanding of what might be causing the growth in the environment.
Bacterial Quantitative Analysis
- This includes bacterial counts and CFU (colony forming units) on the sample after incubation and analysis.
- This is a basic test to show the number of colonies on the sample which allows facilities to compare the results to their acceptance levels to ensure the requirements are being met.
Fungal Isolate Identification
- Identification of fungal species for colonies that grew during incubation and analysis.
- This allows for more information on the potential cause of fungal contamination.
Fungal Quantitative Analysis
- Fungal counts and CFU (colony forming units) identification is available.
- This identification is necessary when fungi is present on the agar plates.
Compressed Air Microbial Analysis
- Viable air testing should be completed on compressed air lines in order to verify proper filtration and cleanliness of the lines.
- This will test for particulate and contaminates present in the compressed air lines.
Procedure & Production Tests
- Air sampling and surface sampling should be used to ensure that the tests and procedures in place are functioning effectively.
Gram Stain Analysis
- Analysis can be completed to differentiate between gram stain positive and negative bacteria.
Bacterial Coagulase Testing
- Analysis can be completed to differentiate between coagulase negative or coagulase positive bacteria.
- The results with a negative coagulation would determine that the bacteria present is coagulase negative and a positive coagulation would establish that the bacteria identified on the sample is coagulase positive.
- These allow for further distinction of what bacteria is present after incubation and analysis.
Media Fill Testing
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.
Personnel/Glove Tip Testing
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.
Method Development
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.
