apa melius ‘mels.n'Standards/On Clean Reomhen Clean Room, Clean Room Equipmonts, Filtration Syston [Schedule of Mandatory Tests to Demonstrate Continuing Compliance in Clean Rooms] (‘Schedule of optional Tests to Demonstrate Continuing Compliance in Cleanrooms] [comparison of international Standards Test Parameter [Class [Maximum Time Interval <= 1505 [6 Months 31805 |12 Months Tr Pressure Dierence | Al Classes [12 Months Airiow ‘AlClasses [12 months Particle Count Test Test Parameter | Class [Maximum Time Interval TnstaledFiter Leakage [Al Classes [24 Months Containment Leakage | Al-Classes [24 Months Recovery ‘All Classes [24 Months ‘Airflow Visualization —[ AlrClasses [24 Months Country and Standard USK 2050 [USA] BritainBS Australia [France | Germany ]150, 2ose | 5295, sizes |AFNOR | vDI2063 NFK 44 101 Date of Current Tasue 1982 [7985 589 1581 1990 [1995 MLS 0.035 = 1 3 M25 0.35 = 2 4 ma.5 35 4000) a 5 M45 35 = 4 6 M55 350 aono00 [5 7 M65 3500 40000006. a [ves of Operations for Aseptic Preparations) ‘Types of Opeartions for Aseptic Preparations Background room cond tons for adivies requiring Grade A Preparation oF Solution to be fired Grade A ‘Aseptic preparation and fling 5 a D Handling of components after wash Note [ves of Operations for Terminally Sterilized Products) Grade A and B correspond to with dass 100, M 3.5, 1505 Grade C correspond to with class 10000, M 5.5, 150 7 Grade D correspond to with cass 100000, M 6:5, 150 8 Grade “Types of Operations for Terminally Sterilised Products Filing fo products, when unusually at risk Placement of ling and sealing machines, reparation of salutons, wen unusvally at risk, Filing of products when unusually at risk molding, lowing (oreorming) operations of plastic containes, Preparation of solutions and components for subsequent fli Note (crear Room Environmental Monitoring) ‘SiN Grade A and B correspond to with dass 100, M 3.5, 1505 Grade C correspond to with class 10000, M 5.5, 150 7 Grade D correspond to with cass 100000, M 6:5, 150 8 Test Frequencyapa Clean Room, Clean Room Equipmonts, Filtration Syston 1 [Parte wontorng ma month 2 [HEPA Fiter integrity Testing, Yeah '3 [Air Changes Rate Calculation Mont a [Ar Pressure Differentials Daal S| Temperature and Humid Dail 6 | microbiological monitoring by see plates and Tor | Dally, and at Gecreased ‘abs in asentic areas frequency in other areas [Seca Requirements for 150 Class 3 Clean Rooms) ‘Special Requirements for 150 Class 3 Cleanrooms: Tair Total Hydrocarbons <1 ppm; Na <0.1 ug/m3 Fresh Air Intake [0.5 m3 /min per sqm of cleanroom floor rea Vibration 0.1 y( Buldng); <0.01 y (Equipment) rms Noise: “= S5-cbA ‘Temperature O.1 degree Humidity <2 Magnetic field var_| <1 mG ‘Static charge 250 (tear Room industry Design Thumb Rule) 150 Controls | Air Velocity at | Air Changes Rate | HEPA Coverage Class ‘table level in perHour | as% of Ceiling PM. 7 __[siingent Too S750 10a, 2 [stringent 70130 3750 109. '3_| stringent 70-130 3750 109, 4 [Stringent 70-110 500 - 605, 109. 5 [stringent 70-90 150 = 400 109, 6 | Intermeciate [25-40 60-100 33-0 7 —_[inwermediate [10-15 25-40. 10-15 1B [ess stringent [3-5 10-15 05-10. ‘mels.n'Standards/On Clean Reomhen 2