Sterilization for pharmaceutical halobutyl rubber stoppers means the application of physical and chemical methods to kill and eliminate transmissible agents (like viruses, bacteria, and spore, etc.) from rubber closures.
Based on different sterilization object, purpose and condition, etc., we have to choose different sterilization methods. The following text will give you some sterilization methods for pharmaceutical halobutyl rubber stoppers.

1. Moist Heat Sterilization
Moist heat sterilization method mainly uses saturated steam or circulated steam for sterilization.
(1) Sterilization by professional washing machines
Professional washing machines can finish all steps from washing, fine cleaning, and moist heat sterilization to final drying.
Sterilization condition: 121℃× (30~40) min
And during sterilization process, the temperature, time and rotational speed can all be preset through PLC.
(2) By autoclave sterilizers
A. Put washed halogenated butyl rubber stoppers into sterilization devices for sterilization. And the sterilization conditions should be: 121℃× (30~40) min. During the process, we have to control rotational speed carefully.
B. Sterilization steps for RFS® rubber stoppers:
Firstly, take off the outer packaging bags (PE bags) in class 10,000 cleanroom; secondly, take out TYVEK packaging bags from PE bags and then put them into autoclave sterilizers. (Note: 1. milky TYVEK side should be face up evenly; 2. sterilizing temperature: 121±2℃; 3. sterilizing time: 30-40 min; 4. the sterilizing cannot finish until the sterilizing indicator turn to brown)
(3) Bathing type sterilization for infusion bottle stoppers

2. Dry Heat Sterilization
Sterilization for powder injection rubber stoppers usually adopt dry heat sterilization, because they often need higher temperature and longer sterilization time: 125℃×(2.5~3.0) h. If adopt drum type sterilization equipment, we have to control the rotation speed carefully (intermittent rotation is also possible).

3. Gamma (γ) Radiation
Before we adopt gamma radiation for halogenated butyl rubber stoppers, we have to know that: (1) Long time and high-dose γ radiation will affect the quality of rubber closures. The molecular chain of halobutyl rubber stoppers contains double bonds. Long time and high-dose γ radiation will damage those isoprene double bonds.
(2) Based on ISO 11171-1997, we know that, gamma radiation sterilization method can guarantee a SAL of 10-6. And the commonly used radiation dose is 25KGY.
(3) Had better adopt low-dose and long time gamma radiation for rubber stoppers, so as to achieve a thoroughly sterilization.
Note: Pay attention to radiation dose, sterilization time and sterilization indicator, etc. during γ radiation sterilization process. And check the quality of halobutyl rubber stoppers after sterilization.

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All in all,
for all pharmaceutical factories,
it is necessary to choose a suitable sterilization method based on the specific medicine you produce.