Ethylene Oxide Sterilizer for Pharma

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Ethylene Oxide Sterilizer for Pharma

Sterile Safequip & Chemicals Limited is an industry leader in the manufacture and supply of cutting-edge sterilization equipment, specifically designed for the healthcare, pharmaceutical, and medical device industries. Our solutions are efficient, safe, and compliant with various regulations to address even the highest standards of sterilization. The pharmaceutical manufacturers all over the world have shown great confidence in our Ethylene Oxide (ETO) sterilizers as their reliable form of meeting their ultimate goal of reliability, performance, as well as the best integrity in sterilizing complex, sensitive materials.

What is Ethylene Oxide Sterilizer for Pharma?

Ethylene Oxide (ETO) sterilization is a gaseous sterilization process with low temperature, which is an effective method of destroying microorganisms, including bacteria, viruses, fungi, and spores, on pharmaceutical products and equipment. It is a sterilization process that exposes items within an ETO gas in a mellow temperature, humid environment, and vacuum cycles that make sure everything is exposed and sterilized.

ETO Sterilizers

Applications of ETO Sterilizers in the Pharmaceutical Industry

Heat and Moisture-Sensitive Products sterilization

The pharmaceutical products, like prefilled syringes, blister-packed tablets, and plastic vials, cannot be exposed to high temperatures or moisture, such as in steam sterilization. ETO sterilization provides a perfect option because the temperature settings used are at low temperatures (37-63 degrees Celsius) and are used to maintain efficacy and stability of sensitive formulations.

Raw material and API packaging Sterilization

Other raw materials, such as Active Pharmaceutical Ingredients (APIs), excipients, and others, are usually packed in materials such as HDPE, LDPE, or aluminium foil. ETO sterilizers give these materials sterility without degrading the packaging.

Medical Packaging Components Sterilization

The pharmaceutical packaging needs to include blister packs, bottles, caps, rubber stoppers, and seals made of aluminum, which have to be sterile prior to tasks being placed in an aseptic environment. ETO sterilizers give a uniform sterilization of these parts without any physical or chemical alteration.

Laboratory and cleanroom sterilization Equipment

ETO sterilization is very common on lab-scale and full-scale cleanroom equipment such as tubing, filters, sampling tools, and gowns, which cannot be sterilized using steam or gamma sterilization.

Combination Product Sterilization

Several drug and device combinations can be found in many pharmaceutical products (e.g., drug-eluting stents, inhalers, or transdermal patches). They need a fine mixture of efficacy of sterilization and product integrity, which ETO sterilization is apt to meet.

Features and Advantages of Sterile Safequip & Chemicals Limited ETO Sterilizers for Pharma

  • cGMP/ FDA Design - The design is compliant with the standards of the USFDA, EU, WHO-GMP, and other global requirements.
  • Flexible Chamber Sizes – Small-scale R&D type through to large-scale industrial types.
  • Advanced Automation - PLC/HMI-based control: data logging, alarms, and cycle validation.
  • Integrated Safety Systems - Multiple failsafe and leak-proof designs in order to ensure operator and environmental safety.
  • Supported Repeatable Cycles and Validable - Enables complete validation of regulatory compliance and batch integrity.

Regulatory & Validation:

Sterile Safequip & Chemicals Limited is providing advice in:
  • IQ/OQ/PQ Documentations
  • Cycle Evolution & Best Practices for Operational
  • U Regulatory (ISO 11135, 21 CFR Part 11, and CE)
  • Annual calibrations & Preventative Maintenance.
  • Integrated Safety Systems - Multiple failsafe and leak-proof designs in order to ensure operator and environmental safety.
  • Supported Repeatable Cycles and Validable - Allows for complete validation of regulatory compliance and batch integrity.

Sterile Safequip & Chemicals Limited takes pride in the provision of high-performance Ethylene Oxide Sterilizers, which are specially designed for the pharmaceutical sector. We create systems with comprehensive knowledge of the pharma manufacturing requirements- the sterility assurance, integrity of products, and the standards according to the global regulations.

To learn more, get in touch with our professional staff at Sterile Safequip & Chemicals Limited.

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