Product Details

Closure Processor

The processing of electrometric closures 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 elastomers used for the closures and the non-compliance to GMP by the manufacturers of these closures.
The BUNG PROCESSOR is designed for a unique dual operation and works as a Steam –Sterilizer to save additional investment and space.

Categories
Tech Specification

Injectable / Sterile Unit Rubber Stopper Washing / Siliconization

All MACHINFABRIK Sterilizers are designed to comply with ASME Pressure Vessel codes, current GMP norms, EN 285, USFDA, EU, PIC etc. The system will be provided with DQ, IQ, OQ documents.
The Closure Processor is a dual-purpose machine and is used for complete processing of rubber closures - washing, rinsing, siliconization, sterilization and drying.
The 6mm thick chamber is fabricated with SS316L with high quality inert gas argon welding and is provided with round corners for easy cleaning and a 2% slope for full draining of the condensate. The chamber is re-enforced with a SS 304, 5mm thick jacket.
The chamber is also provided with a safety valve and compound gauge (on both sides), RTD sensors, pressure switch and pressure transmitter.
The sterilizer is provided with one/two automatic sliding SS316L door reinforced with SS 304/mild steel. Mineral wool insulation is provided which is held in place by a stainless steel outer cover.
CNC machined groove for superior performance and excellent sealing of the door gasket can be provided.
The door is automatically moved vertically / horizontally via a pneumatic cylinder to ensure the safety of the operator and the equipment during the entire operation.
Compound gauges for gasket pressure, with door status indications are provided on both Loading & Unloading sides.
The sterilizer chamber is insulated with 50-mm thick mineral wool, which is held in place by an outer cover of SS304.
The chamber and doors are finished to a surface finish better than 8 micron Ra value. All other non-contact parts are polished to a surface finish better that 180 grit.
The Cabinet Enclosure houses the pressure vessel, piping system, electrical systems and SS 304 facia panels of the unit. Service doors are provided on the sides for maintenance and cleaning.
A cross-contamination seal is provided at the clean side for double door units to separate the clean and unclean sides. The system is designed to minimize the flow of the air from the clean area.
A water ring vacuum pump along with mechanical seal is provided for creating vacuum in the chamber.

A shell and tube type condenser fabricated from SS304 is fitted in the exhaust /vacuum line to condense the steam before entering inside the vacuum pump.
A 0.2μ bacteria retentive, vacuum break filter (hydrophobic type) is provided on the unloading side for pressure equalization after vacuum creation.
All process piping in contact with the chamber is fabricated from SS 316L with argon welding. All connections and fittings used are sanitary tri-clamp with silicone seals.
The process valves in contact with the chamber have SS 316L contact parts with Teflon seat and tri-clamp connections. All other valves have threaded connections.
For periodic validation and testing of the system, Validation Ports with tri-clamp connections are provided.
The chamber can be provided with SS 316L carriage with removable Shelves (perforated/wire-mesh type) for loading. Each carriage is provided with four concave shaped wheels with sealed bearings impregnable to the steam.
Floor trolley is fabricated from SS 304 sturdy tubular members welded together with castor wheels.
The chamber is provided with SS 316L railing with circular cross-section. The rails can be easily removed for cleaning the chamber.
The SS 316L Rotating Carriage consists of a highly perforated drum with a SS 316L gear on the circumference. The Rotary drum is also provided with internal baffles, which assist in the constant motion of the stoppers during washing and subsequent unloading of the stoppers after processing.
The SS 304 Stopper unloading trolley is fitted with a SS chute, which can be steam sterilized. The chute is docked to the Rotary Carriage for unloading. The other end of the chute is provided with a manual valve to start / stop the rubber stopper unloading.
The Stopper processing system consist of an arrangement that drives the rotating carriage at a speed of approx.1 RPM, a detergent and silicone dozing system which can be optionally fitted with a level switch to determine the level of the solution.
For superior cleaning of the rubber bungs a unique triple-punch cleaning system has been provided, which includes continuous injection of compressed air, an overflow action during washing/rinsing and a recirculation filtration system.
In order to ensure the desired level of processing, there is a facility to sample the drain water for suspended particulate matter.
To ensure cleaning of the Rotary Carriage and Chamber between successive washing, rinsing and siliconizing phases purified water is sprayed so that dirt and contaminants from one phase do not pass into the next.
The functioning of the Steam Sterilizer is automatic and is controlled by a PLC. The PLC is operated with the help of a color, touch screen HMI with user-friendly features.
The PLC, instrumentation and electrical switchgear are housed in a SS304 panel installed on the skid.
The control cabinet is provided with a main isolator for the three-phase supply and a separate switch for the control supply.
TEST PROGRAMS
- Vacuum Leak Test
- Pressure Leak Test (optional)
- Bowie and Dick Test.

OPERATIONS PROGRAM
- Warm up cycle.

Gravity Displacement Sterilization Program.
Closure Processing cycle,
Pre-Vacuum with Vacuum Sterilization Program.
SIP of Vent Filter (optional)

A Six-Channel Strip Chart Recorder for recording temperature at 5 points and pressure at 1 point is provided as a watchdog-recording device.
For on-line process recording a data printer is provided in the control panel.
For ease of operation and safety of the operator all critical and non-critical alarms are displayed on the HMI as a text message and audio signal is provided via an audio buzzer.
Optionally, the following features can be provided in the system based on URS:- CE Marking, Electric Steam Generator, Automatic Hinge Door, Vacuum Pump with Recirculation and Cooling System, Vent Filter with SIP Facility, Sanitary PRV for Chamber Steam, Black Steam PRV for Jacket Steam, fittings and tubing to carry out steam quality testing, manual diaphragm valves for sampling of inlet Pure Steam to the Chamber and the steam condensate from the chamber, Air Detector Device in the drain line to generate an alarm in case of presence of air pockets, UPS supply, PID control valves, Pure steam by pass arrangement, drain condenser, sanitary accessories, level switch in drain line, hot air drying arrangement, jacket cooling & monitoring, utility isolation valves & gauges.
The system can be optionally provided with Industrial PC (IPC) or PC with 21CFR Part 11 Compliant System.
Optionally we can provide a 21CFR Part 11 compliant Chartless Recorder with a 4” LCD display.
After manufacturing and in-house testing customer inspection and testing can be performed as per in-house FAT protocol at our manufacturing facility.