Introduction
Antimicrobial preservatives are substances added to products to protect them from microbiological growth (Bacterial and fungal) that are introduced inadvertently during or subsequent to the manufacturing process. In the case of products packaged in multiple-dose containers, antimicrobial preservatives are added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual use doses.
Challenge testing involves the evaluation of antimicrobial efficiacy of the presevative system in accordance with the relevant international standards:
- International Standard ISO 11930
- European Pharmacopoeia (EP) Chapters 5.1.3
- French Standard NF T 75-611
- United States Pharmacopeia (USP) Chapter (52)
ITC Labs capabilities
ITC Labs have well equipped and environmental controlled (AHU system) Microbiological lab with all facilities for Microbial limit test, pathogen testing, Sterlility, vitamin B12, antibiotic assays, Preservative challenge (efficacy test) and related microbial tests.
GRADES |
CLASS | ||
|---|---|---|---|
| DRUG & COSMETIC ACT | USP | ISO | |
| LAF/BIOSAFETY CABINET | A | 5 | 100 |
| MLT ROOM/BIOSAFETY ROOM | B | 6 | 1000 |
| AIRLOCKS | C | 7 | 10,000 |
| MEDIA PREPARATION & STERILIZATION ROOM | D | 8 | 1,00,000 |