BAControl

A quantitative material in which each tablet contains a specific number of viable and culturable cells, obtained by the manufacturer under the test conditions as specified in the Analysis Report.

It is a material which is appropriate for carrying out routine quality control procedures, such as process controls, creation of control charts, or quality control of cultivation media.

It has a shelf life of 12 months after the batch is released. It is provided in cases of 10 vials (containing one tablet per vial) and in 5-tablet dispensers.

We can also prepare reference material coming from environmental isolates.

You will find more information in our

catalog
of reference materials where you can consult the list of stocks in stock. However, if you do not find the strain you are looking for, you can contact us in Reference Materials orders.

You can send us your orders through our email comercial@ielab.es.

Burkholderia cepacia complex and Phamacopoeia

Burkholderia cepacia

Contamination by microorganisms of the Burkholderia cepacia (Bcc) complex has been responsible in the last years for the recall of most non-sterile pharmaceutical products.

The complex Bcc include a group of bacteria resistant to antibiotics and antimicrobial agents that can be able to cause opportunistic infections in immunosuppressed people.

In December 2019, the USP published the new chapter USP<60> “Microbiological examination of non-sterile products-Test for Burkholderia cepacia complex” where the test to determine the absence of Bcc in water, raw materials and non-sterile pharmaceutical products are described.

ielab offers quantitative Microbiological Reference Materials, presented in tablet format, for the different strains indicated in the USP<60>:

  • Burkholderia cepacia ATCC 25416
  • Burkholderia cenocepacia ATCC BAA-245
  • Burkholderia multivorans ATCC BAA-247
  • Pseudomonas aeruginosa ATCC 9027

The USP<60> recommends carry out both Growth Promotion (GP) and Suitability test, thus these Reference Materials are presented in two different concentration ranges:

  • Low range: <100 cfu/0.1mL
  • Extra high range: 107-108 cfu/tablet (105-106 cfu/0.1mL)

 

“IN HOUSE” STRAINS

If any company detects any positive of Burkholderia in its facilities or products, should isolate, identify and conserve the strain to include it in future tests.

Thus, ielab offers to the pharmaceutical, para-pharmaceuticals and cosmetic companies the service for manufacturing Reference Materials from their own strains or isolated strains obtained in their facilities. ielab offers also an identification service by sequencing for the “in house” isolated strains.

PHARMACOPOEIA

ielab offers quantitative Microbiological Reference Materials, presented in tablet format, for the different strains indicated in the European Pharmacopoeia:

  • Escherichia coli ATCC 8739
  • Clostridium sporogenes ATCC 11437 y ATCC 19404
  • Pseudomonas aeruginosa ATCC 9027
  • Staphylococcus aureus ATCC 6538
  • Bacillus subtilis ATCC 6633
  • Bacillus cereus ATCC 11778
  • Candida albicans ATCC 10231
  • Aspergillus brasiliensis ATCC 16404
  • Salmonella spp. serovar Abony NCTC 6017
  • Salmonella spp. serovar Typhimurium ATCC 14028

This materials are available in three different concentration ranges:

  • Low range: <100 cfu/0.1mL
  • High range: >100 cfu/0.1mL
  • Extra high range: 107-108 cfu/tablet (105-106 cfu/0.1mL)

 

DOBLE CUANTIFICATION

ielab offers References Materials quantified (<100 cfu) by means of 0.1 mL spread plate methods, both in general culture medium and in the specific culture medium indicated by the European Pharmacopoeia in section 2.6.13, for each of the following microorganisms:

  • Escherichia coli ATCC 8739
  • Clostridium sporogenes ATCC 11437 y ATCC 19404
  •  Pseudomonas aeruginosa ATCC 9027
  • Staphylococcus aureus ATCC 6538
  • Salmonella spp. serovar Abony NCTC 6017
  • Salmonella spp. serovar Typhimurium ATCC 14028
  • Aspergillus brasiliensis ATCC 16404
  • Bacillus subtilis ATCC 6633
  • Candida albicans ATCC 10231

 

OTHER SERVICES

In ielab we are at the service of our clients and their needs, do not hesitate to contact us for any project or activity in which we can be useful to you, beyond our catalogue products such as:

  • Organization of inter-laboratory tests
  • Internal quality controls
  • Hazard Analysis and Critical Control Points (HACCP)
  • Validation of cleaning or sterilization processes
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