Microbial identification is a critical process that identifies the presence of microorganisms within a specific high-risk area, compressed air system, or controlled environment. One of the main reasons for microbial testing and identification is ensuring the quality of end-products to avoid costly recalls or other issues that arise from contamination.
While some microorganisms are beneficial and part of your everyday health and products, others such as Salmonella and E. coli can cause product contamination or unsafe conditions. Understanding the risks associated with microbial contamination is essential to a robust monitoring plan.
Microbial Identification for Manufacturers
Whether it’s identifying what made a specific product go bad or ensuring the sterility of the production environment, microbial testing can provide useful information. Trace Analytics can test for the number of colonies present, and also identify the growth down to the genus and species. Facilities meeting SQF requirements, annual ambient air testing for high-risk locations is now required. Additional testing may be useful for building microbial trend analyses and ensuring the efficacy of aseptic technique throughout your staff. Identifying these found microorganisms allows manufacturers to understand the level of risk, have clues about the source of the contamination, and make necessary remediation plans.
Sterility and control is of vital importance for pharmacies. The FDA and other governmental bodies have specific requirements that include microbial testing and identification on a regular basis. These strict regulations are in place to ensure the quality of prescription and over the counter medications that are distributed through these facilities. For example, USP 797 describes conditions and practices to prevent harm, including death, to patients that could result from contamination caused by non-sterility. This specification requires the use of a microbial sampler, and an accredited lab, like Trace Analytics, to identify any growth to the genus level, at minimum.
Pharmaceutical and Medical Device Manufacturing
Many pharmaceutical and medical device manufacturing facilities follow standards such as ISO14698-1:2003 –
5.6.2- Enumeration of viable particles from the samples shall be performed only by appropriate validated methods.
5.6.3 -When required, identification, at least to the genus level, can be carried out using established laboratory methods. Information gathered through characterization can help in the evaluation of cleaning and disinfecting procedures in and determining a source of contamination or an appropriate corrective action. Identification of isolates from critical areas will usually take precedence over identification from non-critical areas.
This means that each colony found must be properly identified down to at minimum genus level. For high risk applications like pharmaceutical and medical device manufacturing, microbial identification is an essential part of a successful monitoring program.
How Microbial Identification Works
1. After you collect your sample using swabs, contact plates, the Trio.bas or Pinocchio impaction sampler and ship the sampling media back to Trace, the lab will incubate the samples. The incubation times can vary depending on how many days your chosen specification requires or what organism you’re interested in monitoring.
3. Once microbial contamination is identified, your AirCheck expert will contact you with upgrade options to add on Microbial Identification.
4. You can choose to add-on a full microbial identification to receive the genus / species of your microbial colony, or opt for a Gram stain which will provide you with certain cell morphologies and cellular shape, aiding in further identification.
5. If you choose to further identify your organism, the microbiology lab will restreak the colony for isolation and viability purposes. The organism is mixed into an inoculum fluid and then added into each well of the Microbial Identification MicroPlate.
6. The Biolog then references its library of over 2,900 species to fingerprint ID the microorganism.
7. Your AirCheck report will be delivered by email and will include the TPC, Gram’s stain and genus, species of the colonies requested for upgrade.
Trace Analytics’ Microbiology Lab
To meet the requirements of many specifications, microbial identification must be completed by an accredited laboratory like Trace Analytics. The Trace Analytics laboratory is an A2LA 17025:2017 accredited lab with over 32 years of operation experience. You’ll receive an accredited report for your records. Quality control checks are performed routinely to ensure the highest-quality service for our customers. Our Proficiency Testing Plan ensures that all equipment and processes used are properly validated and calibrated to provide testing to the specification of your choice.
For more information on microbial identification for environmental and compressed air, please complete the form below.