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Home  »  Injectable Projects  »  Rubber Bung Processor Cum Steriliser

Rubber Bung Processor Cum Steriliser

Processing of bungs (electrometric closures for drug containers) is of high concern since they play a significant role in the quality and life of the final product.

The need for correct processing technology is even more important considering the complexities in the compounding of the rubber used for the closures and the non-compliance to GMP by the manufacturers of the electrometric closures.

Considering the criticality of bung processing, our engineers at Neelam Industries with over 20 years of varied technical experience developed a unique 5 in 1 approach as against the conventional method of closure processing.

FEATURES :
  • Rotating carriage : We have designed the rotating carriage that has a triangular cassette sections with perforated sides for hooking the bungs.
  • Sprinkling manifold : The machine is provided with sprinkling manifold arrangement over the rotating carriage to enables uniform sprinkling over the entire lot.
  • Fluidisation manifold : For rigorous fluidization, the Fluidization manifold causes turbulence in the water soaked bungs for effective cleaning.
  • Triple Punch Cleaning system is implemented to ensure through cleaning and sterilization of the closures. This would comprise of the three sub stages mentioned here. A fluidization system with sterile air for mild turbulation of the closures.An overflow system for removing the floating scum and dirt removed from the closures.A recirculation system with filtration for eliminating the dirt released during the process. This also helps in conserving the different process mediums thereby controlling process cost.
  • Facility to sample drain water automatically by the Online Conductivity sensor to ensure Proper washing of the bung.
  • Clean In Place system (CIP) : The BUNG PROCESSOR is fitted with a Clean In Place (CIP) system for washing the chamber and the rotating carriage to prevent the released dirt to be carried out from one phase to subsequent phase. This is particularly important before the start of the "Rinse with purified water" and "Sterilization" phases.
  • Drive System : Neelam Industries developed friction drives to prevent direct metal to metal contact for superior process. Specially developed plastic gears are used to ensures no particle generation during the process and allows the absence of any lubrication.A special non-lubricated mechanical seal is used for pressure and vaccum tight operation of the driving system.
  • Dual Operation : The BUNG PROCESSOR is designed for a unique dual operation.To saves additional investment and space.

PROCESS FOR BUNG WASHING PROGRAMS :
The Process of bung processing are loading, washing with detergent, D.M. water&W.F.I.water rinsing ,siliconization , sterilization and drying.

WASHING
The loaded bungs are washed with detergent solution via a fully automatic detergent dozing system with online conductivity sensor to add the required amount of Detergent in the sterilizer during the cycle.

RINSING
The washed bungs are rinsed with deionized water and WFI water and the quality of WFI water at outlet will be checked automatically to ensure the proper washing of the bungs.

SILICONIZATION
After cleaning closures are siliconized using a silicone emulsion or oil. Siliconization of closures is necessary to prevent the release of plasticizers and other compound added during the compounding of elastomeric closures, to prevent any reaction between the closure and the medication stored or to ensure smooth operation of the machines used for bunging.

STERILIZATION
In Sterilization the closures are sterilized with steam. A pre-vaccum process is employed to ensure effective removal of air and penetration of steam.

DRYING
After sterilization the closures are dried using a vaccum drying process. The drying efficiency is further improved by the continuous rotation of the closures. Process ensures bone dry closures on unloading.

PROGRAMS :
  • Bung Processor (For Washing Bung)
  • HPHV Cycle
  • Fast Exhaust Cycle
  • Slow Exhaust
  • Chamber Leack Test Cycle
  • Bowie Dick Test Cycle
  • Aop Cycle (For Liquid Solution Sealed In Ampoule & Vial)

Sizes available from 430 lts. to 4,000 lts.


AUTOMATION :

Saturated Steam Steriliser
Saturated Steam Steriliser


In compliance with :
cGMP, GAMP, ISO 9001 : 2008

Main applications :
  • Rubber Stoppers washing, Siliconisation and sterilising
  • Empty glassware (e.g. vials, ampoules, bottles)
  • Inox equipment and instruments
  • Inox machine parts
  • Empty containers
  • Filters and accessories
  • Rubber materials
  • Textiles
  • Liquid solutions and culture media in sealed or unsealed containers (e.g. vials, bottles, ampoules)
  • Plastic materials (able to withstand usual temperatures for saturated steam sterilization)

Video Link: Rubber Bung Processor Cum Steriliser video


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