Bung Processor / Autoclave
Definition of Autoclave
An autoclave is a pressure chamber used to carry out industrial processes requiring elevated temperature and pressure different to ambient air pressure. Autoclave is used in medical application to perform sterilization, and in the chemical industry to cure coatings, vulcanise rubber and for hydrothermal synthesis.
Definition of Sterilization
Sterilization can be defined as any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses) from surface, equipment, foods, medications or biological culture medium. A sterility assurance level (SAL) of 10-6 means that there is less than or equal to one chance in million that particular item is contaminated or unsterile following sterilization process.
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, a unique 5 in 1 approach as against the conventional method of closure processing.
Since uniformity of operation on the entire lot of bungs is critical, we have designed the rotating carriage that has a triangular cassette sections with perforated sides for hooking the bungs.
The machine is provided with sprinkling manifold arrangement over the rotating carriage that enables uniform sprinkling over the entire lot.
For rigorous fluidization in the processes of washing and rinsing, the Fluidization manifold causes turbulence in the water soaked bungs for effective cleaning.
The stages of bung processing that will be addressed will be loading, washing with detergent, rinsing, siliconization, sterilization and drying.
The loaded bungs are washed with detergent solution via a fully automatic detergent dozing system.
The washed bungs are rinsed with de-oinized water .that makes the bungs free of particulate matter.
After cleaning the 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.
The closures are then sterilized with steam. A pre-vaccum process is employed to ensure effective removal of air and penetration of steam.
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.
1) 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.
2) Facility to sample drain water and hence select further cycles or to repeat washing till satisfactory.
User defined rinse time and soaking time for the bungs.
3) 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 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.
4) Drive System
MACHINFABRIK has also successfully developed friction drives which prevent direct metal to metal contact for superior process hygiene. Specially developed plastic gears are used which ensures no particle generation during the process and allows the absence of any lubrication.
A special non-lubricated mechanical seal is also used for pressure and vacuum tight operation of the driving system.
5) Dual Operation
The BUNG PROCESSOR is designed for a unique dual operation. This not only saves additional investment but also space, which is critical in any Pharmaceutical facility.
6) Safety Valves for Chamber and Jacket.
Door Obstruction- the door will not open when the chamber is pressurized.
Both doors will not operate simultaneously to protect the integrity of sterile chain.
Basic Qualification approach
User requirement specification (URS)
User or customer of equipment has certain expectation about the equipment which wants to use. These expectations are generally in the form of his requirements. It is called as user requirement specifications.
Design qualification (DQ)
Design qualification may verify that design of equipment, system/facility is according to requirement of user and current good manufacturing practices.
Installation qualification (IQ)
Installation qualification is conducted to prove that equipment/system has been installed as per user and manufacturer recommendation and verifying that all required utilities have provided safe operation of equipment/system.
- Utilities specification
- Drawing specification (electrical, mechanical)
- Construction material in product contact
- Operating and maintenance manual
Operational qualification (OQ)
The operational qualification process is intended to demonstrate that the components are operating properly and ready for performance or load testing. Operational qualification shall be done “without load”
Performance qualification (PQ)
Performance qualification is documented evidence to prove that equipment/system is performing under specified condition. It involve in taking trial under “loaded condition”
Qualification of equipment
Steam sterilizer sterile the article using saturated steam and equipped specifically for application in the pharmaceutical field. Sterilizer is an effective equipment to ensure the sterilization of the garment, cleaning aids filter, utensil, vial filling, machine parts, rubber stoppers etc. The set of main activities for treating the processed materials in order to sterilize them is termed as sterilization process/cycle.
Performance of autoclave
It involve in taking trial under “loaded condition”. The calibration of instruments, apparatus carried out at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision. Operating range, approval standard operating procedure is used for verification. Performance qualification is integrate, procedure, personal, system and material verify pharmaceutical grade utility, and environment, equipment, and system produce required output.
- Autoclaves are inspected every 3 months and certified annually by spore strips.
- The inspection, service and repair records are maintained in the lab.
- The name of the person responsible for the autoclave shall be posted near the autoclave.
- An authorized training session must be successfully completed by users prior to use of autoclaves.
- It is the supervisor’s responsibility to ensure employees are trained before operating any autoclave unit.
- Procedural and instructional documents must be followed.
- Personal protective clothing and equipment must be worn when loading and unloading the autoclave.
Packaging and Loading
- use approved autoclave bags
- prepare and load material to ensure steam penetration
- ensure all containers including bags are vented
- do not overfill containers (prevent spill and boil over)
- ensure sufficient water in load to allow steam penetration
- use secondary containers v label all material (name, contents)
- ensure material is permitted to be autoclave v do not mix clean and contaminated material in the same load
- complete “Daily Autoclave Log”
- do not allow bags to touch or strap sides of autoclave
Operating an Autoclave
- ensure the autoclave is operating properly before commencing
- determine the appropriate exposure time for the load, consider the many factors effecting exposure time
- ensure the autoclave attains the desired temperature (normally 121oC) and pressure (minimum 15 psi) for the desired time (minimum 30 min.)
- record information in “Daily Autoclave Use Log”
- undertake weekly testing using a biological indicator (B. Stearothermophilus.
- Record results on “Biological Test Indicator Results” form.
Unloading the Autoclave
- wait until the chamber pressure gauge reads zero before opening
- Wait 10 minutes for the contents of the autoclave to cool.
- remove the waste in manner reduce the risk of spillage, use a trolley
- Verify temperature and duration of exposure has been met.