Are you a worrier? Do you imagine your validation failing, your QC strains mutating, or an auditor frowning when he or she examines your QC records?
You probably have good reason to worry if you are using a patient sample, the QC strain borrowed from the lab across town, or the strain you froze a few years ago. Below are 10 reasons why using our ready-to-use QC microorganism strains instead can help put your mind at ease.
- Microbiologics quality control strains are traceable to reference cultures deposited at reputable national culture collections. National culture collections only license qualified manufacturers to produce derivatives of their cultures.
- Traceability ensures the microorganisms you purchase have not been subjected to excessive sub-culturing which can lead to mutation. Microbiologics limits passages from reference cultures to three or fewer.
- National culture collections authenticate their strains by using a polyphasic approach to ensure the identity, viability and purity of isolates. This approach combines morphological and physiological analysis with molecular typing methods.
- Microbiologics tests every microorganism lot to ensure that mutations, contamination, or other aberrations have not occurred.
- Ensure accurate, reliable and reproducible results by using strains with known characteristics.
- Quickly determine if a test is out-of-specification by using positive and negative controls.
- Certificates of Analysis can be downloaded from the Microbiologics website. Show them to auditors.
- Instills trust and confidence in your patients or consumers.
4. Reference cultures and their derivatives are recommended as controls
- Who recommends specific reference culture strains for quality control? For starters, the Clinical Laboratory Institute, Standard Methods for the Examination of Water and Wastewater, U.S. Environmental Protection Agency, ISO 11133-2, American Society of Microbiology, and the United States, European, and Japanese Pharmacopeias.
- The US Pharmacopeia states, “Cultures used in compendial tests should be acquired from a national culture collection or a qualified secondary supplier.”
- Qualified secondary suppliers, such as Microbiologics, are ISO 9001 certified and their test methods are accredited by ISO 17025.
- Manufacturers of laboratory test kits recommend reference cultures as controls in their product inserts.
5. Save time and money
- Making your own stock cultures is time-consuming. The microorganism’s identity must be confirmed. Key characteristics must be verified. Passages must be tracked. Samples must be carefully labeled and stored. Freezing requires making aliquots, labeling, and finding room in the freezer.
- Saving time saves labor costs.
- An ultra-low temperature freezer is not necessary for storing Microbiologics QC microorganisms.
- Cultures are readily available and shipped all over the world. You don’t have to wait for a patient to provide you with a positive control.
- Less record-keeping is required.
- Microbiologics offers a product warranty
- Avoid repeating tests due to failed QC.
- Avoid costly recalls and lawsuits. Remember, your company’s reputation is priceless.
6. Strains come with a wealth of information
- Microbiologics provides directions for growing, maintaining, and using microorganisms.
- National culture collections provide genomic, serotyping and toxinotyping data as well as reference sources.
- Public data bases such as GenBank® provide genetic sequencing data.
- The strains are often cited in scientific journals and books.
7. Use commercial strains for validation
Microbiologics QC strains can be used for validation of test procedures. Examples include:
1. Validation of the ability of a test to detect microorganisms in a pharmaceutical, cosmetic product, or in food
2. Validation of alternative methods.
3. Validation of new equipment such as the Vitek®, GeneXpert®, Nanosphere Verigene®, and Bruker MALDI Biotyper Systems.
8. Wide variety of strains available
- Microbiologics provides QC microorganisms for pharmaceutical, food, water, clinical, and university laboratories.
- We fulfill QC needs from Argentina to Zambia.
- Enumerated strains are available for tests such as growth promotion testing of media and disinfectant efficacy testing. Talk about saving time! No need to grow the organism, make a suspension, get out the spectrophotometer, make serial dilutions, and keep your fingers crossed and hope for the best.
- Other microbial products include certified reference material, spores, parasites and slides.
9. Preserve environmental isolates
Worried about fungus that has been showing up on your environmental plates? Think it might turn up in your product? Microbiologics can custom-preserve fungal strains and other microbial isolates. The preserved environmental isolate can be used in validations and quality control of media.
10. Help is a phone call or a click away
- Microbiologics provides technical documents and product information for customers.
- Technical Support personnel are experienced microbiologists who enjoy helping laboratorians from all corners of the world. They can assist in choosing, growing, and testing organisms.
Visit our website to find the right strain and format for your lab!