Why this is an addendum, not a rewrite
- Pro-Cult discs are a first-generation (P1) subculture from NCTC/NCPF master strains under licence from the UKHSA Culture Collections.
- Each label carries both the NCTC and the equivalent ATCC number — bench staff continue using the ATCC nomenclature your existing SOPs reference.
- Per-batch Certificate of Analysis from UKAS Lab #2496 (ISO/IEC 17025) is available online — no audit-day scramble.
- Pro-Cult is an authenticated culture under ISO 13485, not an ISO 17034 Certified Reference Material. Where your method explicitly cites a CRM, source from an ISO 17034-accredited supplier instead.
SOP Addendum — suggested template
- Scope: Add Pro-Cult (NCTC/NCPF-source) as approved alternate supplier for QC organisms listed in [Table X].
- Receipt & storage: Refrigerate at 2–8°C (per label). Allow vial to reach room temperature before opening. Replace cap immediately after disc removal.
- Reconstitution: Disc dissolves in 1–10 mL appropriate broth; recover at 35–37°C for 1 hour; use immediately.
- Documentation: Print the per-lot Certificate of Analysis from the TCS Biosciences UKAS portal (search by Code, Lot Number, Strain, or Strain Designation) and file with the lot release record.
- Parallel-run validation: 30-day parallel testing — run Pro-Cult disc alongside current QC source for the AST panel, growth-promotion test, or sterility-method-suitability test in scope. Document equivalent performance per existing IQCP acceptance criteria.
- Identifier mapping: Update LIS organism master file to associate the NCTC number with the existing ATCC entry (do not create duplicate entries). Both numbers print on the Pro-Cult label.
- Training: Brief bench staff that organism nomenclature is unchanged — only the supplier and disc format differ. Disc softens in 10–15 minutes for direct plating.
NCTC↔ATCC crosswalk — top 20 routine QC strains
| Genus / species | NCTC | ATCC equivalent | Common use |
|---|
| Escherichia coli | NCTC 12241 | ATCC 25922 | CLSI M100 AST QC |
| Pseudomonas aeruginosa | NCTC 12924 | ATCC 27853 | CLSI M100 AST QC |
| Staphylococcus aureus | NCTC 12973 | ATCC 29213 | CLSI M100 AST QC (MIC) |
| Staphylococcus aureus | NCTC 6571 | ATCC 25923 | CLSI M100 AST QC (disk) |
| Enterococcus faecalis | NCTC 12697 | ATCC 29212 | CLSI M100 AST QC |
| Enterococcus faecalis | NCTC 13379 | ATCC 51299 | VRE QC; HLAR detection |
| Klebsiella pneumoniae | NCTC 13368 | ATCC 700603 | ESBL QC |
| Klebsiella pneumoniae | NCTC 13438 | ATCC BAA-1705 | KPC carbapenemase QC |
| Streptococcus pneumoniae | NCTC 12977 | ATCC 49619 | CLSI M100 AST QC (fastidious) |
| Haemophilus influenzae | NCTC 8468 | ATCC 49247 | CLSI M100 AST QC (BLNAR) |
| Neisseria gonorrhoeae | NCTC 12700 | ATCC 49226 | CLSI M100 AST QC |
| Salmonella enterica ser. Typhimurium | NCTC 74 | ATCC 14028 | FDA BAM positive control |
| Bacillus subtilis | NCTC 10400 | ATCC 6633 | USP <61> growth promotion |
| Candida albicans | NCPF 3179 | ATCC 10231 | USP <61> / sterility test QC |
| Aspergillus brasiliensis | NCPF 2275 | ATCC 16404 | USP <61> mould QC |
| Clostridium sporogenes | NCTC 532 | ATCC 11437 | USP <71> sterility QC |
| Listeria monocytogenes | NCTC 11994 | ATCC 19115 | FDA BAM food QC |
| Acinetobacter baumannii | NCTC 13420 | ATCC 19606 | CLSI M100 AST QC |
| Proteus mirabilis | NCTC 11938 | ATCC 25933 | Indole-negative Proteus QC |
| Stenotrophomonas maltophilia | NCTC 10257 | ATCC 13637 | Non-fermenter ID QC |
Equivalences are documented on each Pro-Cult per-lot COA. The full Pro-Cult catalogue covers ~80 strains across 26 genera. Reply to request the catalogue PDF or per-SKU pricing.
Vendor onboarding packet (already prepared)
- ISO 13485:2016 manufacturing certificate (TCS Biosciences)
- ISO 9001 quality management certificate
- ISO 14001 environmental management certificate
- ISO/IEC 17025 batch testing accreditation — UKAS Lab #2496 (verify at ukas.com)
- UKHSA Culture Collections (NCTC/NCPF) licence statement
- Supply-continuity SLA, sample COA, W-9, credit application
Reply with your top 5–10 strains and we will send the per-SKU quote and the full vendor packet.
View this document online: https://www.pro-lab-direct.com/pro-cult/deliverables/switching-sop.html
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