1.0 PURPOSE:
2.0 SCOPE:
This SOP for critical area practices is applicable in critical areas of Injectable area at (Company name).
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1. Personnel entering / working in critical area shall follow the procedure.
4.2. Production Officer / Executive is responsible for the execution of the procedure and to confirm the procedure.
4.3. Head-Production is responsible to ensure the compliance of the procedure.
5.0 PROCEDURE:
5.1. Gowning Practices:
5.1.1. Entry into the critical area is restricted to qualified and trained personnel only.
5.1.2. Visitor / Vendor /Customer representative can be enter into critical area should the gowning procedure.
5.1.3. Person having respiratory problem (cold allergy) skin diseases (sunburn, open lesion and dandruff), stomach disorder shall not be allowed to enter into critical area.
5.1.4. Personnel working in critical area shall under go medical examination once in a year.
5.1.5. Before entering into critical area environment, personnel should understand the responsibilities, critical area techniques and behavior.
5.1.6. Personnel shall remove all the personal belongings and jewelry including items such as rings, watches, etc. in primary change room lockers.
5.1.7. All personnel entering into critical area shall follow the entry and exit procedure.
5.1.8. Personnel working in critical area shall ensure that they shall have daily bath and clean cloths shall be worn.
5.1.9. Dirty cloth must not be worn in critical area.
5.1.10. Personnel working in critical areas shall ensure that their nails are regularly trimmed.
5.1.11. Personnel should keep their hair short and shave regularly in order to minimize the hazards of contamination through hair or beard.
5.1.12. Ensure that the garments are washed and sterilized as applicable.
5.1.13. Ensure that the hand gloves should overlap the gown sleeves.
5.1.14. Hand gloves should be inspected frequently and replace if found torn, contaminated, punctured or dirty.
5.1.15. Change the gown, if the person from Microbiology department has taken the contact plate count on it.
5.1.16. In critical areas observe the gowning of others and instruct them if not properly gowned.
5.1.17. Training shall be given to improve the attitude of staff for successful implementation of personnel hygiene required for critical area.
5.1.18. Critical area garment shall not be used second time without being washed and sterilized.
5.2. Hand gloves and its Sanitization Practices:
5.2.1. The worn sterile gloves shall be disinfected with filtered hand disinfectant solution.
5.2.2. Disinfection of hand gloves with filtered hand disinfectant solution shall be done at least in following situation:
5.2.2.1. At 20-30 min frequency during any operation.
5.2.2.2. When person entering from one class of area to another class.
5.2.2.3. Before and after handling sterilized equipments / accessories / materials.
5.2.2.4. Before and after performing any operation /adjustment in filling room equipments.
5.2.2.5. Before and after any cleaning activity.
5.3. Behavioral practices:
5.3.1. As far as possible avoid direct handling of sterilized material even after disinfection of hand gloves.
5.3.2. The sterilized accessories and materials shall be stored under ceiling suspended LAF / inside Isolator /under mobile LAF.
5.3.3. Movement of person in the critical areas shall be slow, careful without any jerky movement. Rapid movement creates unacceptable turbulence in critical area.
5.3.4. All persons working in critical area shall avoid loud and unnecessary conversation with each other.
5.3.5. While working in front of or below the laminar airflow, do not interrupt the path of unidirectional airflow in the critical processing zone. As far as possible keep, the entire body out of path of unidirectional air.
5.3.6. Ensure that there is no blockage to the return air duct by any equipment, machine, accessories, person, etc.
5.3.7. Do not touch worn garments, floor and walls with gloved hands.
5.3.8. Avoid Sneezing, coughing, itching etc. in critical area.
5.3.9. Do not stand by holding hands on the waist and do not touch any of the surfaces except where desired as per procedure after disinfection.
5.3.10. Personnel should keep their gloved hands away from vial openings, stoppers to ensure minimum interventions during operation or where product getting exposed.
5.3.11. Always use the wrist for pulling the door and the elbow for pushing the door.
5.3.12. Operators shall not take their seat close to their respective workstation.
5.3.13. Operators shall not leave their workstation, unless required.
5.3.14. Sanitize the routine tools used during filling operation with scheduled filtered hand disinfectant solution/ disinfectant solution.
5.3.15. Keep each tool in sanitized container or toolbox after use.
5.3.16. All materials, containers, equipment etc. for usage in critical areas must be labeled and identified.
5.3.17. Clean the cool zone, Filtration and Filling area as per procedure.
5.4. Restricted practices:
5.4.1. Person shall not directly contact sterile product container, closure or critical surfaces.
5.4.2. Unused equipments, materials, accessories, tools, paper, clothes etc should not be stored in the critical area.
5.4.3. The material intended for use in the filling line shall be placed under the respective isolator.
5.4.4. Movement in and out of critical area should be restricted to qualified persons and person should remain for a longer period. In case of emergency or natural calls person can go out.
5.4.5. Talking shall be avoided and whenever necessary should be slow and limited.
5.4.6. No pencils or erasers should be used in critical area.
5.4.7. Verbal communication with people inside critical area should be avoided and if not, shall be slow and use sign language.
5.4.8. Product containers should not be exposed unnecessarily to environment.
5.4.9. Personnel must report any irregularities or adverse changes in environmental conditions of temperature, RH and differential pressure to shift officer/executive.
5.4.10. Avoid the storage of excess materials in the critical area.
5.4.11. Every one working in critical area must follow disinfections schedule and sanitization procedures.
5.4.12. Keep the used gown in the used garments bin. Transfer the used garment for washing.
5.4.13. Materials, containers and equipment introduced in to critical area must be sterilized or disinfected prior to entering critical area.
5.4.14. Critical area doors must be closed at all times they may open only to admit one person or material at a time.
5.4.15. Use lint free and sterilized materials for performing cleaning activity in critical areas.
5.4.16. Personnel, equipment and materials introduced into critical area should be kept minimum.
5.4.17. Personnel must react effectively in emergencies such as fire, electrical failure, and breaking of containers holding toxic or non-toxic substances, illness or injury, explosions.
5.4.18. Waste bins shall be empty at regular intervals.
5.4.19. No flaking or corrosive material shall be allowed in the area.
5.4.20. All materials, containers, equipment etc. for usage in critical area must be labeled and identified.
6.0 ABBREVIATIONS:
No. : Number
LAF : Laminar air flow
RH : Relative humidity
7.0 REFERENCES:
Nil.
8.0 LIST OF ANNEXURES:
Nil.