Dry Heat Sterilization (DHS) is a widely used method for sterilizing heat-resistant medical devices, pharmaceutical products, and laboratory glassware. DHS Validation ensures that dry heat sterilizers effectively eliminate microbial contamination while meeting regulatory standards.
At Prism Calibration, we specialize in DHS Validation services, providing comprehensive testing, calibration, and compliance solutions. Our expertise in sterilization validation helps pharmaceutical, biotechnology, and healthcare industries maintain sterility assurance and regulatory compliance.
– Effective Sterilization of Heat-Resistant Materials: Ideal for sterilizing powders, oils, glassware, and metal instruments that cannot withstand moisture-based sterilization.
– Ensures Endotoxin Removal: Dry heat sterilization effectively destroys pyrogens, making it essential for pharmaceutical manufacturing.
– Regulatory Compliance: DHS Validation ensures compliance with ISO 20857, FDA, EU GMP, and USP guidelines for sterilization.
– Maintains Product Integrity: Unlike steam sterilization, dry heat prevents moisture-induced material degradation, preserving product quality.
– Reduces Contamination Risks: Helps prevent microbial contamination in pharmaceutical formulations and medical device manufacturing.
– Supports Good Manufacturing Practices (GMP): Ensures sterilization processes align with industry best practices and quality assurance standards.
– Hot Air Sterilization: Uses heated air to eliminate microorganisms at high temperatures (160°C–180°C).
– Depyrogenation: Destroys endotoxins in pharmaceutical glassware and vials through extended heat exposure at 250°C–300°C.
– Batch vs. Continuous Processing: Sterilization can be performed in static or conveyor-based dry heat sterilizers depending on process needs.
– Cooling & Handling: After sterilization, controlled cooling prevents recontamination and maintains sterility.
– Monitoring & Validation: Temperature mapping and biological indicator testing ensure sterilization cycle effectiveness.
– Temperature Mapping: Validates uniform heat distribution inside the sterilizer to ensure effective sterilization.
– Biological Indicator Testing: Uses heat-resistant spores (e.g., Bacillus atrophaeus) to confirm sterilization efficacy.
– Depyrogenation Validation: Measures endotoxin destruction in pharmaceutical glassware using LAL (Limulus Amebocyte Lysate) testing.
– Cycle Development & Performance Qualification: Ensures sterilization parameters (temperature, exposure time) meet regulatory standards.
– Physical Parameter Monitoring: Verifies temperature, exposure time, and airflow distribution using data loggers.
– Routine Validation & Periodic Requalification: Ensures continuous compliance and consistent sterilization performance over time.
– ISO 20857: International standard for dry heat sterilization of healthcare products, defining validation and process control requirements.
– FDA 21 CFR Part 211: Regulates sterilization validation in pharmaceutical manufacturing, ensuring drug product sterility.
– EU GMP Annex 1: Provides guidelines for sterile product manufacturing, including dry heat sterilization validation.
– USP <1211>: Establishes standards for sterilization and depyrogenation validation in pharmaceutical production.
– ICH Q7A & WHO GMP: Defines good manufacturing practices for active pharmaceutical ingredients and sterile drug products.
– Validation Protocol & Report: Includes sterilization cycle parameters, test results, and compliance status.
– Certificate of Compliance: Official documentation proving adherence to ISO, FDA, and GMP sterilization standards.
– Calibration Certificates: Ensures accuracy of temperature sensors and validation instruments.
– Regulatory Audit Support: Provides necessary records and data for FDA and GMP inspections.
– Corrective Action Reports: Identifies process deviations and provides recommendations for improvement.
– Established Expertise – Over 20 years of experience in validation services.
– Comprehensive Solutions – SCADA validation, laboratory instrument validation, HEPA filter validation, software validation, and more.
– ISO/IEC 17025-Accredited Lab – Ensuring globally recognized quality and compliance.
-Regulatory Compliance – Meeting FDA, WHO, GMP, and NABL standards.
– Cutting-Edge Technology – Advanced instruments and latest validation techniques.
– Industry-Specific Validation – Tailored services for pharmaceuticals, healthcare, food, and manufacturing.
– Certified Professionals – Skilled engineers ensuring precision and reliability.
– Fast & Cost-Effective Services – Quick turnaround with detailed, audit-ready reports.
Choose Prism Calibration for reliable and compliant validation services backed by expertise and innovation.
Regular validation is recommended annually or whenever modifications are made to the sterilization process.
The temperature typically ranges between 160°C and 300°C, depending on the sterilization application.
Yes, we provide a detailed validation report and a compliance certificate to meet regulatory requirements.
Depyrogenation refers to the removal of endotoxins from pharmaceutical glassware using high temperatures.
We adhere to ISO 20857, FDA, EU GMP, USP <1211>, and ICH Q7A guidelines.
Yes, we offer both on-site and laboratory-based validation for dry heat sterilization.
The process duration depends on sterilizer size, cycle complexity, and regulatory documentation requirements.
Yes, we provide urgent DHS Validation services to minimize downtime for critical applications.
Yes, we offer validation for steam, chemical, radiation, and plasma sterilization.
