Tailored solutions for pharmaceutical and biotech labs seeking to incorporate their environmental isolates or objectionable organisms into routine quality control. Ideal for enhancing contamination monitoring and compliance strategies.
Microbiologics Custom Environmental Isolates enable laboratories to characterise and convert environmental monitoring isolates or objectionable organisms into traceable, reproducible QC-ready formats. Whether for sterility assurance testing, cleaning validation, growth promotion, disinfectant efficacy, or other environmental monitoring validation uses, this service offers complete flexibility and scientific rigour.
Each isolate is preserved and formatted to meet the customer’s specific testing workflows. Microbiologics can supply strains as EZ-Accu Shot™, qualitative pellet, lyophilised format, or other suitable configurations. Custom packaging and label formats are available on request.
Common applications include:
Routine QC testing using site-specific organisms
Validation of EM workflows or decontamination procedures
Supplementing standard ATCC-type strains with real-world flora
Compliance with MHRA, FDA and EU GMP Annex 1 guidance
Microbiologics can also characterise and prepare objectionable organisms for regulatory testing, including their inclusion in challenge or kill curve studies. Strains are traceable, documented, and can be maintained for future reorders.
Organisms successfully used by MSC customers in Microbiologics Custom Environmental Isolate programmes include:
Acinetobacter johnsonii
Acidovorax soli
Aspergillus versicolor
Bacillus cereus
Bacillus circulans
Bacillus infantis
Bacillus licheniformis
Bacillus subtilis
Bradyrhizobium dentrificans
Chaetomium globosum
Corynebacterium tuberculostearicum
Cupriavidus basilensis
Cutibacterium acnes
Micrococcus luteus
Micrococcus spp.
Moraxella osloensis
Pantoea agglomerans
Penicillium chrysogenum
Penicillium spp.
Pseudomonas monteilii
Ralstonia pickettii
Rhodotorula mucilaginosa
Roseomonas mucosa
Sphingomonas melonis
Staphylococcus capitis
Staphylococcus captis
Staphylococcus epidermidis
Staphylococcus hominis
Staphylococcus xylosus
Variovorax paradoxus
If your required organism is not listed above, please contact us — Microbiologics can work with a wide variety of isolates across multiple industry sectors.
Compliance and quality:
ISO 17025 and ISO 13485 accredited
GMP-compliant manufacturing
Fully traceable strain documentation
Secure packaging and shipment
Optional services:
Full genomic characterisation
Mycoplasma, viral and other exclusion screening
Long-term storage of isolates for reorder
Available formats:
EZ-Accu Shot™
Custom lyophilised pellets
Custom suspension formats
Customer-specified configurations (on request)
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