PROCESS
''Producing 5 million components per day makes us one of the leading rubber stopper manufacturing company in India/Asia.''“Unisure RFS” (Ready For Sterilization) Rubber Stoppers
Sequential washing and drying operations are carried out in a fully automated controlled bung processor using a validated washing & drying cycle i.e. with final rinse with water for injection for effective removal / reduction of particulate matter, endotoxin & bio-burden loads as per the internationally accepted norms / limits.
Supplied pre-siliconised and pre-washed with water for injection.
Packed in a steam sterilizable Tyvek bag in clean room environment in the state-of-the-art cGMP compliant plant, equipped with a microbiology lab, HVAC system, water system and other necessary amenities as per the latest pharmaceutical industry requirements.
Comply with the internationally accepted norms for particulate matter, bacterial endotoxin, bio-burden & residual moisture.
Retain samples are maintained from each batch.
COA & sample pack for Q.C / Microbiology testing provided for each batch supplied.
Advantages of RFS stoppers:
Using RFS stoppers will eliminate the complex washing & siliconization steps at user end resulting in saving of time, energy and manpower.
Eliminates many validation activities required at user end, resulting in substantial savings.
No overnight / advance preparation of rubber stoppers required for urgent production schedules.
“Unistar RFU” (Ready For Use) Gamma Sterilized & Low Residual Moisture Rubber Stoppers
Sequential washing and drying operations are carried out in a fully automated controlled bung processor using a validated washing & drying cycle i.e. with final rinse with water for injection for effective removal / reduction of particulate matter, bacterial endotoxin & bio-burden loads as per the internationally accepted norms / limits.
Supplied pre-siliconised, pre-washed and pre-sterilized by Gamma radiation at our own state-of-the-art gamma irradiation facility Universal ISO-MED.
Packed in a clean polyethylene bag under clean room environment in the state-of-the-art cGMP compliant plant, equipped with a microbiology lab, HVAC system, water system and other necessary amenities as per the latest pharmaceutical industry requirements.
Primary pack further protected by two more layers of covering bags.
The triple layer pack is labeled with batch details and gamma radiation indicator and finally packed in corrugated box.
Stoppers are sterilized in their final shipper pack by a validated Gamma Irradiation process.
Retain samples are maintained from each batch.
COA & sample pack for Q.C / Microbiology testing provided for each batch supplied.
Advantages of RFU stoppers:
Using RFU (Sterile) stoppers will completely eliminate the complex washing, siliconising, sterilization and drying steps at customer end, resulting in saving of a lot of time, energy and manpower involved in processing the stoppers.
It eliminates a lot of validations required at customers end, resulting is substantial savings.
No overnight / advance preparation of rubber stoppers for urgent production schedules.
Stoppers with low residual moisture NMT 0.1% especially for the critical dry powder and lyophilized injectable are available upon request.
Customized pack size available on request to suit customer’s requirement.