Rubber Bung Processor Cum Sterilizer

Bung processor which is suitable for operation at a pressure of 1.2 Kg/Cm²/ 2.1 Kg /Cm² corresponding to temperature of 121 °C / 134 °C. the chamber is constructed of heavy-duty stainless steel304/316.

The BUNG PROCESSOR is fitted with a Clean in Place (CIP) system for washing the chamber and the rotating carriage to prevent the dirt released during one phase from being carried over into the subsequent phases. This is particularly important before the start of the "Rinse with purified water" and "Sterilization" phases.

Salient Features:

• sterile Air purging to ensure proper fluidization of the bungs.
• Specially designed Gear to ensure no particle generation.
• Temperature and Pressure Points ensure monitoring of sterilization process.
• Siliconizing through recycling pump.
• Automatic unloading system (OPTIONAL).
• Chamber doors fully meet requirements for sterile environments

Technical Specifications :

• cGMP design Sliding Door Model.
• Automatic PLC Control System.
• S.S. 316 Q. Contact parts and Non Contact parts S.S. 304 Q.
• Suitable for Operation at a pressure of 1.2 Kg/Cm²/2.1 Kg./Cm² corresponding to Temperature of 121 °C/134 °C.
• The Chamber is constructed of heavy–duty Stainless Steel 304/316.
• Capacity 5000/10000/20000/40000 Rubber Stoppers (Bungs).
• In belt Heat Exchanger/pumps etc.
• S.S. Steam Generator (optional).
• HPHV Steam Sterilizer is used for sterilization of liquid, Hard and Hard Porous Material, Glass ware, drugs and surgical instrument used a pharmaceutical. It is also used For Sterilization of containers, vessels, linen, rubber articles culture media etc
• Provide with Sliding doors with high temperature resistant silicone gaskets.
• Standard cycles, HPHV cycles, Bowie Dick cycle & leak test cycle.
• Fully Automatic P.L C. based control system covering all parameters with facility for printing Manual maintenance mode independent to P.L.C. On line printing & recording confirming to 21 CFR PART 11
• Options like electrical steam generator, vacuum pump,carriage, trolleys, chart recorders, data loggers, Dx station etc. Complete S.S 316 or economic model with only contact parts in S.S 316 Fo value display & printing option.

Special Features of Bung Processor Cum Sterilizer :

• Class 100 HEPA filter can be fitted inside and outside. The temperature variation inside the chamber will not be more than 5°C (Hottest Point & Coldest point).
• Special arrangement of baffles is made for the uniform distribution of air inside the chamber.
• Detachable motor with dynamically balanced impellers supported independently on heavy duty bearing.
• Incolloy tubular air heater
• Uniform temperature distribution with the help of well designed adjustable baffle • The trolley design is such that the loaded trolley can be pulled out easily at 65°C due to specially designed wheels.
• Automatic operating controls: relay or PLC based - provision for cycle abortion or continuation in case of power failure; sensors for continuous monitoring of temperature on scanner/printer / data logger with optional printing of FH values 21CFR Part 11 compliance Printing & Recording. Specially designed compact unit for Rubber stopper drying Specially manufactured Silicon door gasket to ensure zero leakage during the operation.
• Black particle generation is totally eradicated with the appropriate design of the heater bank, which is externally removable for maintenance saving time and energy. PLC based control panel. 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.
• Fluidization manifold: For rigorous fluidization, the Fluidization manifold causes turbulence in the water soaked bungs for effective cleaning.

Triple 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 tabulation 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.e 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 vacuum 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, Siliconisation, 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-vacuum 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 of Bung Processor Cum Sterilizer :

• Bung Processor (For Washing Bung)
• HPHV Cycle
• Fast Exhaust Cycle
• Slow Exhaust
• Chamber Leak Test Cycle
• Bowie Dick Test Cycle
• AOP Cycle (For Liquid Solution Sealed In Ampoule & Vial)

Main applications of Bung Processor Cum Sterilizer :

• Rubber Stoppers washing, Siliconisation and sterilizing.

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)