Aseptic area

aseptic area

1. Guru Nanak Institute of Pharmaceutical Science and Technology Presented by- Jinia Rina Ghosh (18601919065) [email protected] Palash Ghosal (18601919066) [email protected] B. Pharm., 3 rd Semester, Section B DESIGNING OF ASEPTIC AREA

2. CONTENTS Introduction Flow diagram of aseptic area Clean-up area Compounding section Aseptic filling area Quarantine section Packing and labelling section Construction of aseptic room Personnel and protective clothing Cleaning and disinfection Conclusion Reference

3. INTRODUCTION What is aseptic condition? Aseptic means something has been made contamination-free, that it will not reproduce or create any kind of harmful living microorganisms. A condition with no microorganisms. What is aseptic area? Area which is kept contamination-free. Production of sterile products is executed using different aseptic techniques. Limit for the environmental quality of microbial and dust particle contamination. Production area is divided into: The clean-up area The compounding area The aseptic filling area The quarantine area The packaging and labelling area Fig: Aseptic area [1]

4. FLOW DIAGRAM OF ASEPTIC AREA [1]

5. Walls and ceilings are made up of film coating material. High efficiency (95%) air filter are present. Air inside the clean area should be free from dust and microorganisms. Air replacements are done frequently(10-15 air change per hou r). CLEAN-UP AREA Fig: Clean-up area [1,2]

6. Actual compounding takes place. Contains stainless steel cabinets and counters and is involved in the actual compounding. Maintenance of sterile conditions is not essential, but necessary measures should be adopted to avoid contamination. COMPOUNDING SECTION Fig: Compounding area [1,2]

7. Control measure should be taken to avoid contamination. Stainless steel counter and cabinet should not accumulate dust. Mixing and the storage of the compounded preparation should be done outside the aseptic area. Compounded preparation is transferred to this area and filling takes place. Strict control measures is adopted to avoid contamination. ASEPTIC FILLING AREA Fig: Aseptic filling area [1,2]

8. Process batches as well as approved batches are stored separately. Limited access. under the control of a responsible person. Without the consent of the in charge, other personnel cannot enter. QUARANTINE SECTION Fig: Quarantine section [1,2]

9. Here, batches are packed and labelled . Packing is carried out by packaging machines, while labels by over printing devices. At a time, only one product labels are printed. Parenteral packing plays a vital role. Sterility of the product is maintained. PACKING AND LABELLING AREA Fig: Packing and labelling area [1,2]

10. Smooth, easy to clean and disinfected. Flexing and non-flexing material can be used. Walls are must be made of non-inflammable material 1% of 8-hydroxyquinolone, pentachlorophenol, etc may be added to the paint for anti-fungal action. Epoxy resin paints and polyurethane paints are also used. Ceilings are sealed. Internal fittings are kept minimum. CONSTRUCTION OF ASEPTIC AREA FLOORS , WALLS AND CEILINGS Fig: Construction of aseptic area [3]

11. Doors and windows should fit flush with walls. Windows should be non- openable . All pipes passing through the walls of the room should be sealed Gases should be piped from outside the area. Sinks and drains must be excluded. Light sources are fitted with the ceilings. Switches should be installed outside. CONSTRUCTION OF AEPTIC AREA DOORS, WINDOWS AND SERVICES Fig: Construction of aseptic area [3]

12. Neat and reliable personnel. They should be in good health and free from dermatological conditions. Trained personnel for GMP. The operator should wear sterile protective clothing. All protective clothing must be sterilized. Fresh sterile clothing should normally be provided each time . PERSONNEL AND PROTECTIVE CLOTHING Fig: Protective clothing [3]

13. Cleaning agents are the alkaline detergents and ionic surfactants. Quarternary ammonium compounds, sodium hypochloride , ethanol and formaldehyde solutions are used as disinfectants. Cetrimide or chlorhexidine in 70% alcohol are suitable for use as skin disinfectants. CLEANING AND DISINFECTION Fig: Cleaning and disinfection in aseptic area [3]

14. This was the designing of aseptic area and its construction. Strict control measure should be adopted to avoid contamination to the products. Cleaning and sterilization should be done on a regular basis and personnel should be careful to avoid contamination. Sterilized and protective clothing should be worn by each and every persons. Thus, sterility can be maintained and contamination can be avoided. CONCLUSION [1]

15. Jain NK. Pharmaceutical microbiology, 2nd edition, Vallabh Prakashan , Delhi.2007, page no - 294-305. Manivannan R. Singh, B. Patel YKK, Pharmaceutical microbiology, 1st edition, Thakur publication Pvt limited, Lucknow,2018, page no - 216-226 Jennie W, Judith A R, Ian S. Pharmaceutical Practice, Churchill Livingstone, Elsevier. 5th edition Production of sterile products,2014, page no - 371-384 REFERENCE