Sterilization biological indicator GP3-9372

medicallaboratoryfor the pharmaceutical industry

Introduction
Biological indicators (BI) for monitoring the efficacy of space/gas sterilization processes such as ozone, formaldehyde and chlorine dioxide. Supplied with Staphylococcus albus 8032 and Bacillus atrophaeus ATCC9372. Designed for use in pharmaceutical production, medical device manufacturing, CDC and biosafety laboratory environments.

Product form / Components

• Stainless steel strip and paper strip carriers
• Stainless steel sheet carrier to minimize false positives
• Tyvek® packaging to permit sterilant penetration while preventing external contamination

Storage & Shelf life

• Bacillus atrophaeus ATCC9372 storage: 2–8 °C
• Staphylococcus albus 8032 storage: ≤ -18 °C
• Shelf life: 12 months or 6 months depending on product type

Compliance & Quality
Biological indicators directly assess the lethality of a sterilization cycle. Product quality is ensured through traceable spore production and documented performance data. Test reports include spore concentration, D-value and related metrics. Tailin’s BIs comply with international and regional standards for healthcare product sterilization.

• ISO 11138 Biological indicators for sterilization
• GB18281 Biological indicator
• USP 1229 Sterilization of Compendial Articles
• USP 55 Biological Indicators - Resistance Performance Tests
• USP 1035 Biological Indicators for Sterilization
• Ph.Eur 5.1.2 Biological indicators and related microbial preparations
• PDA TR51 Biological Indicator for Gas and Vapor-Phase Decontamination Processes
• FDA 510(k), GMP

Applications
Intended for pharmaceutical manufacturers, medical device producers, public health agencies (CDC), biosafety laboratories and any facility requiring validated gas/space sterilization monitoring. Technical support and documentation are available to assist process validation and regulatory submission.

Specifications / Technical characteristics

• Intended sterilants: ozone, formaldehyde, chlorine dioxide (space/gas fumigation)
• Biological strains: Staphylococcus albus 8032; Bacillus atrophaeus ATCC9372
• Carrier types: stainless steel strip, paper strip, stainless steel sheet carrier
• Packaging: Tyvek® packaging to allow sterilant penetration while preventing contamination
• Storage conditions: Bacillus atrophaeus ATCC9372 at 2–8 °C; Staphylococcus albus 8032 at ≤ -18 °C
• Shelf life: 12 months or 6 months depending on product
• Traceability: spores are traceable; test report includes spore concentration and D-value
• Standards: ISO 11138, GB18281, USP (1229, 55, 1035), Ph.Eur 5.1.2, PDA TR51, FDA 510(k), GMP
• Typical end-users: pharmaceutical manufacturers, medical device industry, CDC, biosafety laboratories