Objectional organisms are the main contributor for recalls. Pharmaceutical microbiologists have the great responsibility of ensuring their products are free of harmful contaminants and safe for consumers. Therefore many pharmaceutical companies now implement standard operating procedures to test products and the environment for the presence of several representative strains. These strains are often selected from amongst their own bacterial and fungal isolates (from environmental monitoring, sterility or bioburden testing).
Importance of Environmental Isolate Testing
- Objectionable organisms are the primary reason for recalls. Some data show as much as 72% of recalls are caused by environmental isolates.
- When environmental isolate testing is done correctly, manufacturers can have confidence in their finished products and protect their brands by avoiding public product recalls.
- Identification should be performed on every contaminant to determine if it is objectionable.
- If the isolate is objectionable, the source of the contaminant should be investigated to determine the cause.
What does the FDA consider as objectional organisms?
- Burkholderia cepacia
- Escherichia coli – indicator of fecal contamination
- Pseudomonas aeruginosa
- Salmonella species – pathogenic
- Shigella species
- Staphylococcus aureus – poor production hygiene
- If a sterile manufacturing process is used, all organisms are deemed objectionable.
Maintaining these strains in-house can be a time-consuming and costly practice.
MSC, in conjunction with our partner Microbiologics, provide a turn-key professional preservation service to the pharmaceutical microbiology laboratories called Microbiologics Custom Solutions.
Microbiologics Custom Solutions service is designed to make the use of environmental isolates just as convenient, easy and precise as using any of our ready-to-use formats for QC testing.
Custom Solutions will enable customers to implement best practices in media QC for their critical environmental monitoring and sterility testing.
Advantages of this type of service include:
- Accreditation
- Experience
- Quality
- Finished goods storage
- Cost-savings
- Product warranty
- Test-ready formats
How it works
- Once the strain is identified in your facility, submit the Custom Solutions Request Form including details about your strain and test applications.
- We’ll send you a quote for review and approval.
- A shipping box will be sent to your laboratory containing the supplies required to send us your isolate.
- When your strain arrives at Microbiologics’ facility, it will be identified, preserved and manufactured in an easy-to-use format that best meets the needs of your laboratory.
- Turnaround time is typically 8-10 weeks from the time we receive the isolate
- This service is fully confidential!
Why choose EZ Accu Shot format for your custom solution?
- It provides a fast, convenient and reliable solution for Growth Promotion Testing, Media Challenge Testing and more.
- Each instant-dissolve microorganism pellet is designed to deliver 10-100 CFU per inoculum
- Up to 8 hours stability allows for ultimate flexibility
- 50 tests per kit, ideal quantity for labs of any size
- Refrigerated storage is easy and economical
- Accredited reference material under ISO 17034 standard
To receive further information or to request a quotation please contact us below
For more on our range of Microbiologics click here
