PURPOSE
To lay down a qualification SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area. The role of manufacturing department and quality control departments is to perform environmental monitoring.
SCOPE
This SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area is applicable to Sterility testing area of microbiology lab and sterile injectable facility. The scope for aseptic processing is suitable for sterility testing field of sterile injectable capacity and microbiology laboratory. The SOP is mainly applied for the qualified individuals only for controlling the entry, exit and aseptic area gowning.
RESPONSIBILITIES
Microbiologist and all personnel are responsible to full fill the qualification requirements while entering sterile area.
The responsibility of manufacturing and quality control supervisors has focused on ensuring proper execution of job role of manufacturing and quality control executive through getting proper training and applying the monitoring procedures and equipment.
The role for quality control team is to approve the rejection of all the specifications or procedures which has impacted strength, identity, purity and quality of the drugs products.
The role of filter user is to review the validation information on the filter efficiency in production of sterile effluent filter.
REFERENCES & REQUIREMENTS
WHO guidelines
USP
DEFINITIONS & ABBREVIATIONS
SOP: Standard operating procedure
PROCEDURE
Personnel Qualification
- The SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area of Microbiology lab are qualified by undergoing into three kinds of tests.
- Training on Aseptic Area Behavior and Importance
- The personnel whose are intended to go into the both the areas are must aware of the aseptic area behavior and their importance:
- Training on Aseptic area behavior and importance
- Physical gowning procedure verification
- Gowning procedure qualification by the microbiological method
Prerequisites
- Personnel must be shaved properly.
- Hair must be trimmed.
- Nails must be trimmed
- No ornaments like Rings / chains / Watches / Threads are allowed to take in to the aseptic area
- Mobile phones are not allowed
- Should not have a cough, cold and sneezing problems.
- Person must not have any open cuts, wounds and open lesions
- Person must not have any skin diseases.
- Must apply disinfectant / sanitizing agent whenever he enters into the area.
Aseptic area behavior and importance
- Personnel must wear the Primary garment first the followed by the secondary garment.
- Elbow length glove must wear after complete gowning.
- Hair must be covered completely at any part of the body.
- Avoid exposure of the body to the area.
- Do not touch floor, wall while and after wearing the garment.
- Minimize the contact of the surfaces with the hand glove.
- Avoid brisk walking.
- Should not make loud / whistle voice.
- Avoid talking in the area.
- Do not lay down on the floor
- Intimate to the In-charge if any un-comfort and come out of the area.
- Record the details provided.
- Viable and non-viable particles are the main agents of the contamination in clean rooms.
- Personnel is the main source of contamination.
- Personnel are tending to shed particles, these particles may carry viable organisms.
- Viable and non-viable particles are the particles, which will spoil the integrity of the aseptic area.
- Because of the wrong practices and behavior may lead to the higher viable and non-viable particle generation.
- Enter the details in the record.
Physical Gowning procedure verification
- Personnel who are responsible to enter into sterile area, they must undergo training and qualification of physical gowning procedure verification.
- The personnel are taken into the Office room of the Production, and there training on gowning procedure will be given.
- There the personnel are provided with mock area entry/ exit facility. The person must wear, gown and display all the steps properly.
- He / She must not skip or miss any step.
- He / She must follow the gowning sequence.
- He / She must not touch any part of outer surface of the garment/ glove while wearing the garment.
- A trained supervisor shall monitor all the above steps.
- After complete satisfactory gowning procedure display, He / She allowed going into the further microbiological qualification test.
- Record all the observations.
Gowning procedure qualification by microbiological method
- After successful completion of the above 2 steps (6.2 & 6.3) the person is allowed to undergo gowning qualification by the microbiological method.
- The person is taken into the room by following the SOP after wearing the Primary and Secondary garments as per the SOP.
- Trained microbiologist shall collect Microbiological Swabs and Finger dabs after the person completes his / her gowning in all respects.
- The person shall come out of the area by following respective entry-exit procedure.
- The collected swabs or plates shall be transferred to microbiology lab for further testing and incubation.
- Swabs shall be tested for the microbial count by membrane filtration method as per SOP.
- Finger dab plates and swab tested plates are incubated at 30-35°C for 5 days.
- The identified results are within the limit, the person is qualified to enter into the aseptic area.
- If the person is failed to show the results within the limit, he/ she are not qualified to enter into the aseptic area.
Frequency
- Initial and Re-Qualification of the personnel
- Initial Qualification: Whenever a new person entry is required.
- Periodic Qualification: A qualified person undergoes periodically for his correctness. Once in 6 months.
- Re-qualification:
- Case-I: A person who fails to show aseptic practices / Gowning procedure / excessive microbial count in regular personnel monitoring tests.
- Case-II: A person who is not regular attendee to the aseptic area gowning procedure (Above 3 months) willing to go into the aseptic area. Or a Person who availed longer medical leaves more than a month and willing to go into the SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area