In a pharmaceutical plant, drug solutions, packaging containers, production equipment and materials entering an aseptic area may all need to be processed. Heat-resistant items can be treated with steam or dry heat; heat-sensitive liquids can be sterilized by filtration; and isolator interiors are commonly biodecontaminated with vaporized hydrogen peroxide.
Understanding the principle and typical conditions of each method helps teams select suitable materials for equipment components and isolator gloves.
1. Steam sterilization
Also called moist-heat sterilization, this process removes air from the chamber so saturated steam can contact the load, then holds it at the set temperature for a specified time. Pharmaceutical plants use it for utensils, equipment components and packaging assemblies that tolerate moist heat. Some production systems also use steam-in-place (SIP). (EU GMP Annex 1)
121°C for 30 minutes is a common example of a steam exposure period. Higher-temperature, shorter-time cycles are also used for suitable equipment and loads. The holding period begins after the load reaches the specified temperature; heating and drying are other stages of the cycle. (CDC: Steam Sterilization)
2. Dry-heat sterilization
Dry heat uses hot air to process a load. Common reference conditions are 160°C for 120 minutes or 170°C for 60 minutes. Pharmaceutical plants use dry-heat ovens for heat-resistant items and continuous dry-heat tunnels for glass containers such as vials. (CDC: Other Sterilization Methods)
Dry-heat treatment of glass can also provide depyrogenation. This targets contaminants such as endotoxins, so the temperature, dwell time and performance criteria differ from ordinary dry-heat sterilization. (EU GMP Annex 1)
3. Sterilizing filtration
Liquids that cannot withstand steam or dry heat can pass through a sterilizing-grade membrane to retain microorganisms, then be filled under aseptic conditions. Filters commonly used in pharmaceutical processes have a nominal pore size of no more than 0.22 μm. The filtration system is compatible with the liquid, and integrity testing confirms the condition of the filter. (EU GMP Annex 1)
Filtration processes only the liquid or gas passing through the membrane. Filling containers, tubing and equipment components receive their own appropriate treatment.
4. Gamma irradiation
Gamma irradiation uses ionizing radiation to inactivate microorganisms. It is used for suitable heat-sensitive materials, single-use components and packaged products. The key parameter is the absorbed dose, measured in kGy. 25 kGy is a common reference dose; the appropriate dose is set for the product and process. (EU GMP Annex 1; ISO 11137-2)
For polymer products, the effect of irradiation on strength and elasticity also matters. Whether an isolator glove is suitable for gamma irradiation depends on its material and product-specific irradiation compatibility.
5. Ethylene oxide sterilization
Ethylene oxide (EO) is a gas sterilization method for selected items that cannot tolerate high temperatures and whose packaging allows the gas to enter. A complete cycle includes temperature and humidity conditioning, gas exposure and aeration. Gas concentration, temperature, humidity, pressure and exposure time define the process conditions. (EU GMP Annex 1)
Because EO residues must be controlled after processing, manufacturers consider the product material, packaging structure and aeration time together when using this method.
6. Vaporized hydrogen peroxide (VHP) biodecontamination
VHP introduces hydrogen peroxide vapor into an enclosed space such as an isolator, where it contacts chamber walls, equipment surfaces and installed gloves. A cycle typically includes conditioning, vapor injection and contact, followed by aeration. Pharmaceutical plants commonly use it to biodecontaminate isolator interiors for aseptic production. (EU GMP Annex 1)
VHP processes account for hydrogen peroxide concentration, temperature, humidity, contact time and gas distribution. During treatment, gloves are extended and the fingers separated so the agent can contact the glove surfaces.
7. Ozone treatment
Ozone controls microorganisms through oxidation. Pharmaceutical water systems can use ozone for chemical disinfection; dedicated equipment can use an ozone sterilization cycle for suitable items. Component selection takes account of ozone concentration, contact time and material resistance. (WHO: GMP for Water for Pharmaceutical Use)
Kingsure EPDM and CSM isolator-glove sterilization performance
Kingsure EPDM and CSM isolator gloves support the following steam-autoclave conditions and maximum cycle counts:
| Glove material | Steam-autoclave conditions | Maximum cycles |
|---|---|---|
| Kingsure EPDM isolator glove | ≤121°C for 30 minutes, or ≤130°C for 10 minutes | 150 |
| Kingsure CSM isolator glove | ≤121°C for 30 minutes, or ≤130°C for 10 minutes | 60 |
Both materials support hydrogen-peroxide disinfection (300,000 ppm / 24 hours), peracetic-acid disinfection (15% / 24 hours), ozone disinfection (200 ppm / 72 hours) and gamma-ray treatment. Their sterilization performance meets the sterility requirements for medical and pharmaceutical industrial use.
Download the Chinese sterilization declaration or English sterilization declaration.
Steam, irradiation and VHP treat different items under different conditions. Kingsure provides EPDM and CSM isolator gloves for pharmaceutical processes and different steam-sterilization cycle needs.