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Clean Room
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- 2. What is aClean room? • “Federal Standard 209E” defines a clean room as a room in which the concentration of airborne particles is controlled to specified limits. • “British Standard” defines a clean room as a room with control of particulate contamination, constructed and used in such a way as to minimize the introduction, generation and retention of particles inside the room and in which the temperature, humidity, airflow patterns, air motion and pressure are controlled
- 3. Principles Of TheClean Environment • Air is highly (HEPA) filtered (99.97% @ 0.3μm) • Layout should minimize particle sources in filtered air stream • Air flow should remove most particles generated by process
- 4. TYPES OF CONTAMINATION •Particulate Dust, skin, hair, makeup… • Chemical Oil, grease, metal ions, perfume… • Biological Bacteria, fungi, rodents • Radiation Ultraviolet light…
- 5. CONTAMINATION SOURCES • People~75% • Ventilation ~15% • Room Structure ~5% • Equipment ~5% CONTAMINATION CONTROL •Personnel Control •Dress code •Personal Hygiene •Gowning •Environmental Control •Entrance and exit •Materials and supplies •Cleaning and maintenance •Atmospheric (HVAC & Microbial monitoring)
- 6. PERSONAL HYGIENE • Showereach day before entry • Control Dermatitis & Dandruff • Do not smoke before or after entry • No chewing gum or tobacco • No Cosmetics , Jewellery or wrist watches should be worn • Leave all personal items in changing room (wallets,keys,comb etc.) • Avoid coughing and sneezing if unavoidable leave the clean room • Do not move vigorously(Brisk movements shed large particles from body movement)
- 7. There are TwoStandards today Firstly, Federal Standard 209
- 8. In 2001, ISO14644-1 replaced Federal Standard 209E on basis of clean Room classification Federal Standard 209E ISO 14644-1 They measured 0.5µm and larger But ISO 14644-1 standard take account even smaller particles ranging from 0.1µm to 0.5µm per cubic meter of air Classified based on that range
- 9. Classification Of CleanRoom ISO 14644-1 Classified based on amount of micron particles in one cubic meter of air
- 10. Classification Of Air& Micro-organism As Per WHO Guidelines
- 11. CLASSIFICATION AS PEREU cGMP For examples in Blister packing Temp 21c Humidity 60-40% Pressure 15pa
- 12. Schedule M Schedule M:Contains various regulations for manufacturing, premises, waste disposal and equipment for pharm units in India
- 13. Gowning • Proper gowningorder – Hair cover – Hood – Shoe covers – Coverall – Gloves – Face mask – Safety Glasses • Cotton garments shed fibers. Hence, not used
- 14. AIR HANDLING SYSTEM: •Requirements – Temp should be 15-25 °C. Atleast 20 air changes should be there per hr. Cleanliness requirements i.e. class 100. Relative humidity 45-55 %. Pressure differential between 2 area should be 0.05-0.1 inch water gauge.
- 15. Hvac systems inclean room http://pune.All.Biz
- 19. HEPA & UEPA HIGHEFFICIENCY PARTICULATE AIR (HEPA): They are box type depth filters used for air filtration. These filters are made up of glass fibers. Efficiency of HEPA filters are 99.97% against 0.3 μm particles. Testing for HEPA filters: Hot DOP test (efficiency testing), Cold DOP test (integrity testing) , Air flow resistance test ULTRA LOW PENETRATION AIR (ULPA): Most ULPA filters are replaceable extended media dry filters that have a minimum particle collection efficiency of 99.9997 % efficient for particles greater than or equal to 0.12-micron in size.
- 20. AIRFLOW DISTRIBUTION ANDCONTROL • Unidirectional:(sometimes referred as laminar flow) is an airflow pattern in which essentially the entire body of air within a confined area moves with uniform velocity and in single direction with generally parallel airstreams. Clean rooms; class 100 and below have unidirectional airflow pattern. Laminar air flow ----120 FPM • Non-unidirectional: airflow is not unidirectional by having a varying velocity, multiple pass circulation or nonparallel flow direction. Conventional flow clean rooms (class 1000 & 10000) have non-unidirectional or mixed air flow patterns. • Mixed patterns : combine some of each flow type.
- 22. Entry & Exit •Enter and exit quickly. • Only one person may enter at a time. • Each user must use their own access card. • Pass from the gowning area to the clean area slowly to reduce migration of particles between areas. • Restricted no. of people in aseptic area. • Drug sensitivity tests should be carried out for employees working in critical area. • Medical check-ups of people works in critical area should be more frequent than other employees. Some specific requirements
- 23. TEST FREQUENCY Particle Monitoringin air--------------6 monthly HEPA Filter Integrity Testing---------Yearly Air Changes Rate Calculation-------6 Monthly Air Pressure Differentials--------------Daily Temperature and Humidity------------Daily Microbiological monitoring by---------Daily
- 24. • Current GoodManufacturing For pharmaceuticals; Manohar A. Potdar; Page no:70-73. • Pharmaceutical Quality Assurance, Manohar A. Potdar , Nirali Prakashan; Page no:13.1-13.10 • Comparison of Quality Requirements for Sterile Product Manufacture as Per Indian GMP and USFDA ;Yogita P, N Vishal Gupta, Natasha NS, Ashwini Nageen L, R Sudeendra Bhat; Research Journal of Pharmaceutical, Biological and Chemical Sciences; Jan 2012 volume 3(1): 225-236. • www.fda.gov Reference