Facility Validation

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FACILITY VALIDATION

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FACIITY QUALIFICATION PURPOSE: - to provide guidelines for checking facility construction and finishing to ensure that they meet the facility design qualification requirement Responsibility: - It is the responsibility of all concerned managers and contractors to follow the procedure. The quality assurance manager is responsible for SOP compliance Procedure The conceptual design of the facility (approved civil layout) should be available and be compared with the actual construction. Details should be summarized in a tabular form describing: Room number Activity Room classification (e.g., class 100, 10,000, etc.) Utilities required and their quality (e.g., WFI, distilled water, compressed air, etc.) Room finishes (floor, walls, ceilings, partitions) Illumination Safety features Pass-throughs Communicators Prefabricated partitions

Materials and quality checks The quality of materials used shall be confirmed from the purchasing specification and the materials receiving reports. Generally, the use of wooden materials is not recommended. 1. Materials and quality checks for floor Sr. No. 1 Quality check points *Floor–wall joints, building columns, equipment pads, and other obstructions should be completely sealed. *Floor drains should be provided only where large volumes of liquids are anticipated *The floor should be pitched toward the drain (if available) to prevent accumulation of liquids *The floor drain should not be located in the aseptic clean room because of concerns about microbiological growth in the trap. *Trapped floor drains should be provided Observation Acceptance criteria Material used should be like Epoxyresin-welded PVC sheets and epoxy terrazzo

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2. Materials and quality checks for walls Sr. No. Quality check points Observ -ation Acceptance criteria

1 Construction materials shall be free from seams, cracks, or holes, and also washable, clearable, and free from rust or corrosion Walls should be smooth, rigid, and resistant to impact and abrasion Walls should be protected by physical barriers such as stainless steel subrails (if necessary). Wall surfaces should be easy to clean and resistant to repeated exposure to disinfectants Floor–wall, wall–wall, and ceiling–wall intersections should be properly sealed to prevent dirt accumulation and pest entry Floor–wall and wall–wall joints should be coved Ledges should accumulation be sloped to reduce dust

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Material used should be like Seamless PVC coating, Welded sheets of PVC, Prefabricated wall panels, Epoxy coating & Polyester coating.

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3. Materials and quality checks for ceiling Sr. No. 1 Quality check points Construction materials shall durable, cleanable, and washable be Observation Acceptance criteria Material used should be like Gypsum board with epoxy Polyster coating Seamless PVC coating

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Ceilings should be smooth, nonperforated, and properly sealed to the framing All penetration through ceilings must be designed to establish and maintain the integrity of a 100% sealed system

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4 The suspension system should be heavy-duty aluminum with anodized or leaked-on, even-finish stainless steel

4 Materials for doors and quality checks for entry ways, doors and air locks Sr. No. 1 2 Quality check points Construction materials, door openings and door gaskets should be satisfactory Glass fixing should be satisfactory (if used). Entry of all personnel, materials, and equipment should be through a suitable air lock The design and arrangement should minimize migration of particulate and other contaminants into the controlled process area. Door should have automatic closing systems Locks and latches should be avoided Observation Acceptance criteria Material used should be like Standard painted timber Timber with plastic lamination Glass Stainless steel

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5 Quality checks for windows Sr. No. 1 Quality check points Materials shall be durable, washable, and cleanable. Windows between class 100 areas and other areas should have sloping sills on both sides of glass to facilitate cleanliness. Observation Acceptance criteria

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6 Quality checks of Construction and Finishes Sr. No. 1 Quality check points Observation Acceptance criteria

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Rooms should be designed and constructed so that air leakage through openings or penetration is kept to a minimum. All surfaces must be completely cleanable and resistant to germicidal solutions. Horizontal or other surfaces on which dust can accumulate shall be kept to an absolute minimum, and they shall be completely avoided above areas where the product or washed product containers are exposed.

7 Quality checks of Curtains and Partitions Sr. No. 1 Quality check points To maintain the cleanliness classification and protect the critical areas of equipment from air turbulence, the following equipment should be surrounded by a curtain: Equipment Curtain Material Curtain Height Observation Acceptance criteria

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8 Quality checks of Conveyor Passages and Partition Holes Sr. No. 1 Quality check points The passage of conveyors through partition is adjusted using polycarbonate sheets cut as needed. Observation Acceptance criteria

9. Quality checks of Utility Lines Check Sr. No. 1 Quality check points Observatio n Acceptanc e criteria

Check and ensure that utilities are installed per the room requirement list: Industrial steam Pure steam Chilled water Tap water (warm) Tap water (cold) Distilled water Water for injection Compressed air Nitrogen gas Exposed piping and conduit should be avoided as much as possible. Exposed piping should be completely cleanable by being set out approximately 1 to 1.5 in. from the wall or other surfaces. Check that all piping is properly labeled with flow directions.

10. Quality checks of Safety Features Sr. No. 1 Quality check points Check and ensure that safety equipment is installed per room requirement list: Observation Acceptance criteria

Location, condition, and number of water showers available Location and number of fire extinguishers available Location, condition, and number of smoke detectors available Location and number of emergency doors available 11. Quality checks of Drainage System Sr. No. 1 Quality check points Drainage should be designed and constructed per approved layout. Verify the drainage locations using building specification. The floor should be pitched toward drain holes to prevent accumulation of liquids. All surfaces must be clearable. All drains should have deep seal traps to avoid back-flow (nonreturn valves). Open drains should be avoided in manufacturing and packaging areas. Process and sanitary drains should be separate to avoid the possibility of introducing sanitary waste into process systems. Drains must be covered with secured lids. Check that drain flushing procedure is established and identified. Check that drainage lines are sanitized according to procedure and that records are available. Check that drainpipe slope is toward outside. Observatio n Acceptanc e criteria

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