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Pharmaceutical Grade Sterilizers

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Pharmaceutical grade sterilizers are the highest standard of sterilization equipment, utilized in the manufacturing of drugs, injectable products, and medical devices where compliance with **Good Manufacturing Practice (GMP) is mandatory. These units are large, often horizontal, floor-standing pass-through autoclaves designed for absolute precision, repeatability, and comprehensive audit trails. Key features include advanced control systems (e.g., PLC)**, jacketed chambers for rapid and uniform heating/cooling, and highly accurate temperature/pressure sensors. Unlike standard medical autoclaves, pharmaceutical models require extensive **IQ/OQ/PQ (Installation, Operational, and Performance Qualification)** to legally validate that the equipment functions precisely according to the required process specifications. They sterilize everything from bulk raw materials and culture media to final packaged devices and vial/ampoule loads, forming a critical controlled environment barrier.

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Specification

ParameterDetail
Grade StandardGMP and GxP Compliance (FDA, EMA)
Sterilization LoadVials, Ampoules, Bulk API, Filters, Culture Media
Sterilizer TypeHorizontal, often Double-Door (Pass-Through)
Process ControlAdvanced PLC Control with 21 CFR Part 11 Data Logging
Key RequirementRigorous IQ/OQ/PQ Validation Package
Chamber DesignFully Jacketed (For rapid, uniform thermal transfer)
FeaturesAir-Over-Pressure Cooling (for sealed container loads)
ConstructionHighest Grade SUS 316L Stainless Steel (Product Contact)

Application

The essential operational environment is within cleanroom facilities in pharmaceutical, biotechnology, and medical device manufacturing plants. The double-door, pass-through design is critical for maintaining the barrier between a non-sterile manufacturing area and a sterile filling/packaging cleanroom, preventing microbial contamination. These sterilizers run critical terminal sterilization cycles for liquid injectables (in vials), requiring precise control over the air-over-pressure cooling to prevent the sealed containers from rupturing. They are also used to sterilize filtration systems and the equipment parts that will enter the cleanroom. Every cycle must be recorded, validated, and meet the specific $F_{o}$ (lethality) requirements outlined in the product's regulatory filing, making the integrated data logging system a core functional component.

Transaction Details

These are high-value, specialized capital goods. Payment terms are strictly structured, often involving a letter of credit (L/C) or phased T/T payments tied to production milestones and regulatory documentation approval. Shipping is handled by specialized international carriers under DDP terms due to complex installation. The price always includes the full IQ/OQ/PQ documentation and on-site commissioning by certified factory engineers. Lead times are extensive (16-30 weeks) due to the customization and rigorous quality control required. Buyers must conduct a detailed site survey and collaborate closely with the manufacturer to align the equipment specifications (e.g., cleanroom wall thickness, utility access) with their facility's GMP requirements. The warranty covers the pressure vessel and the entire control system for reliable long-term GxP operation.

Advantage

The main advantage is the unmatched precision, reproducibility, and verifiable compliance required by global pharmaceutical regulations. The fully jacketed chamber and advanced controls ensure rapid, uniform temperature distribution, which is essential for achieving a precise and auditable $F_{o}$ value throughout the load. The specialized air-over-pressure cycle safely sterilizes sealed liquid containers without bottle breakage, a critical function for injectable product lines. The comprehensive validation package (IQ/OQ/PQ) provides the regulatory confidence needed to bring a drug or device to market. While the initial investment is high, the equipment's long-term reliability and the assurance of GMP compliance are non-negotiable for commercial sterile manufacturing, offering protection against catastrophic product recalls.

FAQ

  • Q: What is $F_{o}$ and why is it critical in pharmaceutical sterilization?
  • A: $F_{o}$ (F-naught) is a measure of microbial lethality based on time and temperature (usually at $121.1^\circ\text{C}$). Regulatory bodies require documented proof (via $F_{o}$ calculations) that the sterilization process achieves a $10^{-6}$ Sterility Assurance Level (SAL), ensuring safety for the patient.
  • Q: What is a "pass-through" design?
  • A: A pass-through autoclave has two doors, one opening into the non-sterile area and one into the sterile cleanroom. This design prevents cross-contamination, as materials can only move from dirty to clean after sterilization.
  • Q: Why is 316L stainless steel required for the chamber?
  • A: SUS 316L is a low-carbon, high-chromium stainless steel that offers superior corrosion resistance to chlorides and aggressive cleaning agents, which is essential for pharmaceutical environments where the chamber must be routinely cleaned and maintained to prevent product contamination.
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Wanrui Medical Instrument

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86-15728040705
86-18957491906

86-15728040705
86-18957491906