Biological and Chemical Indicators - Image 1
Pharmaceutical

Biological and Chemical Indicators

Shreedhar Group's sterilization indicators can support sterilizer validation, routine monitoring, quality assurance, and GMP-focused operations. They are suitable for applications where reliable sterilization monitoring plays an important role in product and process safety.

 

  • Biological Indicators (BIs) are available in multiple formats including self-contained indicators, paper strips, stainless steel carriers, and spore suspensions, allowing flexibility for different sterilization loads and applications.

 

  • Chemical Indicators (Cls) are mainly used to monitor various sterilization processes and confirm that the sterilization conditions meet the requirements through color changes.
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Product Overview

Our Biological and chemical  Indicators (BIs) are designed to directly monitor the effectiveness of sterilization processes by evaluating the survival of specific microorganisms. They are the most reliable tools for sterilization validation, routine monitoring, and re-validation across pharmaceutical, medical device, and laboratory environments.

 

Biological Indicator :

Our biological indicators comply with ISO 11138, GMP, FDA 510(k), USP, EP, and ChP requirements, ensuring global regulatory acceptance.

 

Technical Highlights

  • Storage Conditions: 2–25°C or 2–8°C (product dependent)
  • Shelf Life: Up to 12 months
  • Packaging: 30–50 pcs per pack

Test Organisms:

  • Geobacillus stearothermophilus
  • Bacillus atrophaeus
  • Bacillus subtilis

Types of Biological Indicators

  • Biological Indicators for Vaporized Hydrogen Peroxide (VH₂O₂)
  • Biological Indicators for Autoclave Steam
  • Spore Suspension for Moist Heat
  • Biological Indicators for Hydrogen Peroxide Low Temperature Plasma
  • Biological Indicators for Gas Fumigation

 

Chemical Indicators :

Tailin's Cls for monitoring the sterilization of steam, hydrogen peroxide and ethylene oxide meet the requirements of GB 18282.1/ISO 11140 and other relevant standards. Used together with Bls to ensure the safety of sterilization.

 

Cls have special sensitivity to specific environmental factors (e.g., temperature, humidity chemicals, etc.). Cls will change color according to these factors to assist in determining the effectiveness of the sterilization.

 

Technical Highlights

  • Storage Conditions: 2–25°C
  • Shelf Life: Up to 12 months
  • Packaging: 200 pcs per pack

Applications: 

  • Autoclave Steam Sterilization
  • Vaporized & Atomized Hydrogen Peroxide
  • Hydrogen Peroxide Plasma
  • Ethylene Oxide (EO)
  • Dry Heat Sterilization
  • Ozone & Gas Fumigation

 

For pharmaceutical manufacturers, laboratories, hospitals, and other controlled environments, dependable sterilization indicators can strengthen documentation and quality-control practices. ISO 11138-7 provides guidance for selecting, using, and interpreting biological indicators during sterilization development, validation, and routine monitoring.

 

Choose Shreedhar Group's Biological and Chemical Indicators for Sterilization to support reliable sterilization monitoring and stronger quality assurance. Contact us today for product specifications, availability, and expert assistance.

Key Features

Direct Measurement of Sterilization Lethality : Confirms sterilization effectiveness based on microbial survival.
Wide Sterilization Compatibility : Suitable for steam, hydrogen peroxide, plasma, ethylene oxide, dry heat, ozone, and gas fumigation.
Multiple Formats Available : Self-contained, paper strip, stainless steel carrier, ampoule, capsule vial, and spore suspension.
Fast & Clear Results : Color-changing culture media provides accurate results within 48 hours
Patented Design : Less than 10% medium evaporation during incubation, compliant with GMP requirements.
High Spore Purity & Traceability : Spore purity >99% with complete test reports including spore population and D-value.
Customization Available : Custom spore concentration and D-value available as per customer requirements