David W. Vincent Figure 6 Controlled Environment Design and Construction Specification Recommendations Physical Make-up or Room Finishes ClassificationLevels Parameter imum Requirement Is05 | Iso6 | Is07|Iso8 Ceiling . Drwal with epoxy, plastic polyester (atleast two R | R R [R + To be smooth, and cleaning agent resistant. R_|_R R R | aie > Plastic, epoxy coated plaster, dry wall, or panel systems | R | R R |R To provide and maintain a smooth acid and cleaning, agent resistant surface. = Coved, seamless. R|_& RT R aes * Coving such that no dust collecting ridges are found, R_|_R R_[R * Floors it areas where operations discharge water or NAT NA |N R liquid product waste onto floor should be sloped to a drain and sealed to facilitate cleaning, * Required for monitoring purposes and communication. R_[_R__|_NA_| NA oe + Must be flush, no ledges. R_|—R~ [NR | NR + Ifledges are present, they must be slanted. na [wa | R [RR + Framing to be flush (hardware should be stainless or R | R R [NR Doors equivalent) any hardware should have a minimum of protrusions. u Eee 7 Z * Gaskets and door sweeps may be required to maintain | | A RNR pressure differentials (non-shedding or particulate producing.) = * Gaskets may be required for differentials (non- shed= R | R R {NR ding or particulate producing). = No panic bars are allowed. aR R_ [NR + Shadowless and uniform intensity at 100 to 150 foot Lighting candles at work surface. i Hee R_| NA | NA | +70 to 100 foot candles at work station. NAT NA [ R_[R * Light fixtures should be sealed to prevent air leaks; | flush mounted are preferred. R R NR_| NR | + Electrical panels, distribution equipment, and panels R | R RR | Electrical and starters or related components that are not re- Design uired for daily operation in clean rooms should be installed in unclassified areas + Conduits entaring the clean room should have seal fit R | R R |R tings attached to them just ahead of the entrance point that prevents outside air and pests from coming into clean room through raceways of electrical components. + Light switches should be installed outside clean rooms. RR NR [NR ~ Tf switches and receptacles are present, they should R R NR [NR | have gasket weather -proof SS or anodized aluminum covers and be located high enough above the floor as possible, out of reach of hose-down cleaning activities = No protrusions, ledges or exposed piping are allowed. R |_R | NA [NR General * Access doors in walls and ceilings should be limited R_|~R__|-NR [NR = No drains. R_| A |-NR [NR + Drains, if present, should be designed with atmosphere | NA [NA | R | R February 2008 + Volume 12, Number 2 SEDDavid W. Vincent Figure 6 (Continued) Controlled Environment Design and Construction Specification Recommendations Physical Make-up or Room Finishes ClassificationLevels Parameter | Mi ium Requirements 1so5 | Iso6 | 1s07| Iso8 General break or check valve to prevent back flow (trap seal primer is required). + Process drains and “sanitary” drains should be sepa- | NA | NA R | R rated with a running trap. + Gross connections between process and “Sanitary” NAT NA | R [R systems should be avoided, ‘+ All process pipe lines or service lines whose contents R R R R ‘come in contact with product or praduct contact sur- face (such as steam and compressed air) should be sloped back to source or to a planned low point drain outside of controlled area, + Duct work downstream of HEPA fillers should be RR R R Ductwork stainless steel with no leakage, * Special care and precautions are required to maintain R A R TR Cleanliness, be sioped back to source, or to a planned low-point drain outside of controiled area. Should be clean at time of installation and remain so R R | R until commissioning, — * Suitable test ports should be available Tor verification R R [A of integrity of HEPA fitter, = Access space fo ducts and filters should be provided ‘with entrance outside the clean area, NR | NR minimizing problems involving pipe integrity. * Ductwork should be made of material that is impervi- ‘ous to sanitizing chemicals or products that contain R R R NR | NR R R R * Flexible ductwork should be limited to short distances R R sodium chloride. * Protective laminar flow equipment required or R] NA [NA | NA Equipment laminar ceiling. li + Won-shedding or minimal particulate shedding eauip- R | R R [NR ment and material allowed in room (mainiy stainless steel | + Proper covers and barriers contain contamination RR R TR from moving parts. _ + All components should be sterile when brought into RR RNR room, + Where air in equipment will contact steriized mater- R | R R yR ial, bacterial retentive fiters are required (ie., Lyophilizer vacuum breaks, hot air sterilizer vents), ‘These must be integrity tested at least annually. ‘+ Maintenance programs must be defined and logued. R ATR | a + Class 100 (Dynamic) R_[ NANA | NA Air + Class 10,000 (Dynamic) _NA | R NR_ [NR Classifications [+ Class 100,000 (Dynamic) Na_| NR R_|NR * Class 100,000 (Static) NA | NAT NA [R Gourmet of vatication TechnologyDavid W. Vincent Figure 6 (Continued) Controlled Environment Design and Construction Specification Recommendations Physical Make-up or Room Finishes ClassiticationLevels Parameter _| Minimum Requirements 1s05 | ISO6 | Iso7|Iso8 + Min. 85 changes/he (85 - 150 preferred) nr_| NR | NR Air Changes [+ Min. 50 changes/hr (50 - 75 preferred) _ Rg NR_ | NR + Min. 20 changes/hr (20 - 50 preferred) NA R NR * When doors are open, outward air flow should R|_R R TR be continuously sufficient to minimize ingress of ‘contamination. Air Velocity | + 90 + 20 ft. min 6 Inches above productWwork surface B_| wa | wa | NA Temperature | + 22°C +2°C preferably cooler in aseptic filing rooms. ata ne [nr © 220440 NA | NA R R | Relative * 3010 50% R R R R Humility Pressure +A pressure differential of atleast 0.06 in water with ROR R | NA Differential doors closed * A pressure differential present with doors closed and rR | oR a |R open. Re Required, NR= Not Required, NA= Not Applicable February 2006 + Volume 12, Number 2 D>