Importance of Environmental Monitoring
Environmental monitoring (EM) and microbiological testing both play critical roles in the healthcare, pharmaceuticals and medical device industries by providing confidence in the manufacturing environment along with the final bioburden (microbial content) of the finished product.
Implementing a robust EM program involves risk assessments, qualified site-specific sampling plans as well as setting appropriate control limits. In addition to these, procedures are required to interpret the data correctly & avoid making incorrect assumptions (often made due to a limited understanding of the test methods).
Validated microbiological testing, in combination with a robust EM program, helps to maximize a manufacturers' confidence in their products while ensuring the safety of the end user.
ams Laboratories work closely with our clients to establish a comprehensive EM program specifically designed for their facilities, processes and products with appropriate action/alert limits. In addition, we can also assist in trending and interpreting the EM data.
With the recent introduction of our MicroSEQ (genetic sequence) & Vitek-MS identification systems, ams Laboratories can characterize environmental isolates to the species and strain level. The MicroSEQ allows us to create client-specific customized libraries for individual manufacturing facilities. If required, we also provide long-term storage of these isolates for inclusion in disinfectant qualification studies, growth promotion testing of media fill studies, antimicrobial efficacy testing, etc.
Process water testing is another aspect of environmental monitoring programs that helps to ensure your water system is operating under appropriate control and assists in the early detection of microbial and/or endotoxin contamination.
Both our offices in Sydney and Brisbane are TGA Licensed and NATA accredited ensuring we can provide the highest level of quality testing to support your individual needs.
Contact us now to find out how you can start.