which type of container use for sterilization of rubber bungs
You must use SS316L conatiner for bung sterilization process.
There are reasons and specifications for this
- Bung is a primary packing component.It has direct impact on the product.
-SS 316L is less reactive to any of the products that are comming out during bung washing and sterilization process.
-This container should be with out dents, very smoothly polished so that stagnent water does not stay or stick and will be removed easily.
I want to add one ore thing SS container should be perforated type to allow the steam to penetrate the inner area of bungs.
Why not tyvek bags?
Stopper Bags are made from Tyvek® and a polyethylene/HDPe flexible film. This combination of materials yields superior seal strength for stoppers and other critical items.
Designed to be autoclaved, these bags are lint-free, moisture resistant, puncture resistant and extremely tough,offers high breathability while providing an effective bacterial barrier. The clear film side offers excellent clarity combined with strength and durability.
For Indian prespective these bags are very expensive.They have to be imported and attracts duty.The disposability is also a problem too.
When compared EU/US/Canada/Australia Stainless steel is much cheaper and affordable in India by Pharmaceutical manufacturers.There are many fabricators who fabricate equipments adhering to DN-ISO standards of quality.
So that means that in places other than India, one would use tyvek bags to sterilize bungs. How do you get the bungs out of the SS container and into a RABS or Isolator filling line?
Those who can afford having RABS and Isolators are using TYVEK bags.They are all doing Oncology products which have high returns. Iam speaking about rest of lot.Pharma & Biotech Industry in India is not far behind than US/EU in Technology, Skill and capacities.
The Tyvac packed sterilised bungs are transfer through Betas which are SS containers. This Beta ports container attached to the alpha ports of Isolator or RABS and they are transferred to the designed location. The alpha and beta port are designed as lock and key where the beta (which is sterilised) port is directly opened in the sterilised Isolator or RABS chamber.