FACILITY VALIDATION PROTOCOL
To ensure that the Facility installed, for the Production Granulation area conforms with the predetermined acceptance criteria.
SCOPE OF FACILITY VALIDATION: –
To perform the Facility validation for the Production Granulation area.
RESPONSIBILITY: –
Validation Executive
Engineering Executive
Production Executive
PROCEDURE: –
Check the facility as per acceptance criteria in the granulation area and record the observations in the report as per the Installation checklist.
Document any discrepancies or variations noted during the Facility validation for
Production Granulation area. Record the corrective actions taken to rectify the discrepancy in the report.
Record abbreviations used in the report.
Attach all related documents to the report as an annexure and record in the report.
Finally, functional heads shall summarize, conclude, and approve the report.
ACCEPTANCE CRITERIA:
The facility checklist shall include the following points.
Location/Room no./Purpose of area for use/Dimension of area
Dimension
- Height (Meter)
- Length (Meter)
- Width (Meter)
- Area (M2 / Ft2)
- Volume (M3 / Ft3)
A] CIVIL WORKS:- Carry out the following checks to civil works.
WALLS:
WALL MATERIAL: Brick wall with cement mortar
CRACKS/ CREVICES: There shall not be any cracks/crevices on the wall
SURFACES: The wall surfaces shall have smooth surfaces
TYPE OF PAINT APPLIED: Synthetic enamel /Oil bound distemper
COLOUR SHADE: Honey Dew
FLOORING:
FLOOR MATERIAL: Kota stone / Shabad stone / Ceramic Tile (Based on the area)
COVING: Floor-to-wall corners shall have smooth coved surfaces
CREVICES: There shall not be any crevices on the floor.
SLOPE TOWARDS DRAIN: The slope shall be proper to easily flow water towards the drain.
EASE OF CLEANING: The floor surfaces in the area shall be easy to clean.
STONE JOINT MATERIAL: Epoxy / Cement (Based on the area)
CEILING:
CEILING MATERIAL: Gypsum board / Cement concrete (based on the area)
CRACKS/ GAPS AT LIGHT FIXTURES: There shall not be any cracks/gaps on the ceiling, at light fixtures.
TYPE OF PAINT APPLIED: Synthetic enamel / Oil bound distemper
COVING:: Ceiling-to-wall corners shall have smooth coved surfaces
COLOUR SHADE: Dull white
DOORS:
MATERIAL OF CONSTRUCTION: Aluminum frame with partly laminated bison and partly glazing
MARKING OF PUSH / PULL: PULL / PUSH shall be marked on all doors.
FRAME ATTACHMENT TO WALLS: There shall not be any projections or crevices between the frame and the wall surface
WINDOWS:
MATERIAL OF CONSTRUCTION: Aluminum frame with fully fixed tough / plane / frosted glass
NUMBER OF WINDOWS: Based on the area requirement
FRAME ATTACHMENT TO WALLS: There shall not be any projections or crevices between the frame and the wall surface
B] ELECTRICAL WORKS: Carry out the following checks for electrical works.
WIRING:
CONCEALING OF WIRING: All the electrical cables shall be concealed
ELECTRICAL SOCKETS: Joints between electrical sockets and wall surface shall be coved.
NO. OF SOCKETS/ CAPACITY: Sockets of 5-15 amp or 20-30 amp capacity based on the area requirement.
LIGHTING:
NO. OF LIGHT FIXTURES: Based on the area requirement
LUX LEVEL: 150 to 300 – Storage areas and 250 to 400 – Process areas
C] AIR HANDLING SYSTEM: Carry out the following checks concerning AHU.
NO. OF INLET AIR GRILLS & GRILL DIMENSIONS: Based on the area requirement
NO. OF RETURN AIR GRILLS GRILL DIMENSIONS: Based on the area requirement
TEMPERATURE: 22 ± 2º C.
HUMIDITY: i) 50 ± 10 % and ii) 35 ± 5%
NUMBER OF AIR CHANGES/HOUR: i) NLT 30 and ii) NLT 15
PRESSURE DIFFERENTIAL: All the process areas shall have negative pressure concerning the internal corridor.
D] SERVICES/UTILITIES: Carryout the following checks concerning services and utilities
COMPRESSED AIR:
NO. OF POINTS: Based on the area requirement
SIZE OF PIPELINE / MOC: ½ inch, SS 316
MOC OF CONTROL VALVE: Teflon-coated SS sheeting
LEAKAGE: There shall not be any leakage found.
POTABLE WATER:
NO. OF POINTS: Based on the requirement
SIZE OF PIPELINE / MOC: ½ inch, SS 316
MOC OF CONTROL VALVE: SS 316, diaphragm valve
LEAKAGE: There shall not be any leakage found.
PURIFIED WATER:
NO. OF POINTS: Based on the requirement
SIZE OF PIPELINE / MOC: ½ inch, SS 316
MOC OF CONTROL VALVE: SS 316, diaphragm valve
LEAKAGE: There shall not be any leakage found.
CHILLED WATER:
NO. OF POINTS: Based on the requirement
SIZE OF PIPE LINE /MOC: ½ inch Galvanized Iron pipeline.
MOC OF CONTROL VALVE: Nickel-coated SS sheeting
LEAKAGE: There shall not be any leakage found in the chilled water pipeline.
DUST EXTRACTION:
NO. OF POINTS: Based on the area requirement
MODE OF EXTRACTION: Negative suction using motor
E] EQUIPMENT: Carry out the following checks to equipment.
CLEANING: The equipment shall be cleaned as per the relevant cleaning SOP.
MAN / MATERIAL MOVEMENT: There shall be adequate space for man and material movement.
INSTALLED EQUIPMENTS: The equipment relevant to the operation shall be installed.
F] SAFETY: Carry out the following checks related to Safety.
ACCESSIBILITY EMERGENCY DOOR: The emergency door shall be easily accessible in the area. Emergency door shall be marked with separate label.
ACCESSIBILITY TO FIRE EXTINGUISHER: Fire extinguisher shall be easily accessible in the area with SOP.
ACCESSIBILITY TO FIRST AID BOX: Information regarding the first aid box shall be available in the area.
G] SANITATION
AREA CLEANING: The area shall be thoroughly cleaned as per the relevant SOP.
FUMIGATION: Carry out the fumigation for all critical areas.
Specifications for fumigation: 84 gm. of Potassium permanganate in 0.252 kg of formalin per 1000 cu.ft of area.
AREA SETTLE PLATE: Carry out the area settle plate as per SOP.
Total microbial count: NMT – 100 CFU/ plate
Total fungal count: NMT – 10 CFU /plate
CIVIL WORKS:- Carry out the following checks with respect to civil works.
WALLS:
WALL MATERIAL: Brick wall with cement mortar
CRACKS/ CREVICES: There shall not be any cracks/crevices on the wall
SURFACES: The wall surfaces shall have smooth surfaces
TYPE OF PAINT APPLIED: Synthetic enamel / Oil bound distemper
COLOUR SHADE: Honey Dew
FLOORING:
FLOOR MATERIAL: Kota stone / Shabad stone / Ceramic Tile (Based on the area)
COVING: Floor-to-wall corners shall have smooth coved surfaces
CREVICES: There shall not be any crevices on the floor.
SLOPE TOWARDS DRAIN: The slope shall be proper to easily flow water towards drain.
EASE OF CLEANING: The floor surfaces in the area shall be easy to clean.
STONE JOINT MATERIAL: Epoxy / Cement (Based on the area)
CEILING:
CEILING MATERIAL: Gypsum board / Cement concrete (based on the area)
CRACKS/ GAPS AT LIGHT FIXTURES: There shall not be any cracks / gaps on the ceiling, at light fixtures.
TYPE OF PAINT APPLIED: Synthetic enamel / Oil bound distemper
COVING: Ceiling-to-wall corners shall have smooth coved surfaces
COLOUR SHADE: Dull white
DOORS:
MATERIAL OF CONSTRUCTION: Aluminum frame with partly laminated bison and partly glazing
MARKING OF PUSH PULL: PULL / PUSH shall be marked in all doors.
FRAME ATTACHMENT TO WALLS: There shall not be any projections or crevices between the frame and the wall surface.
WINDOWS:
MATERIAL OF CONSTRUCTION: Aluminum frame with fully fixed tough / plane / frosted glass
NUMBER OF WINDOWS: Based on the area requirement
FRAME ATTACHMENT TO WALLS: There shall not be any projections or crevices between the frame and the wall surface
B] ELECTRICAL WORKS: Carry out the following checks for electrical works.
WIRING:
CONCEALING OF WIRING: All the electrical cables shall be concealed
ELECTRICAL SOCKETS: Joints between electrical sockets and wall surface shall be coved.
NO. OF SOCKETS CAPACITY: Sockets of 5-15 amp or 20-30 amp capacity based on the area requirement.
LIGHTING:
NO. OF LIGHT FIXTURES: Based on the area requirement
LUX LEVEL:150 to 300 – Storage areas and 250 to 400 – Process areas
C] AIR HANDLING SYSTEM: Carry out the following checks concerning AHU.
- OF INLET AIR GRILLS GRILL DIMENSIONS: Based on the area requirement
- OF RETURN AIR GRILLS
GRILL DIMENSIONS: Based on the area requirement
TEMPERATURE: 22 ± 2º C
HUMIDITY: i) 50 ± 10 %
NUMBER OF AIR CHANGES/HOUR: i) NLT 30
PRESSURE DIFFERENTIAL: All the process areas shall have negative pressure on the internal corridor.
D] SERVICES/UTILITIES: Carryout the following checks concerning services and utilities
COMPRESSED AIR:
No. OF POINTS: Based on the area requirement
SIZE OF PIPE LINE /MOC: ½ inch, SS 316
MOC OF CONTROL VALVE: Teflon-coated SS sheeting
LEAKAGE: There shall not be any leakage found.
POTABLE WATER:
NO. OF POINTS: Based on the requirement
SIZE OF PIPE LINE /MOC: ½ inch, SS 316
MOC OF CONTROL VALVE: SS 316, diaphragm valve
LEAKAGE: There shall not be any leakage found.
PURIFIED WATER:
No. OF POINTS: Based on the requirement
SIZE OF PIPELINE / MOC: ½ inch, SS 316
MOC OF CONTROL VALVE: SS 316, diaphragm valve
LEAKAGE: There shall not be any leakage found.
CHILLED WATER:
No. OF POINTS: Based on the requirement
SIZE OF PIPELINE /MOC: ½ inch Galvanized Iron pipeline.
MOC OF CONTROL VALVE: Nickel-coated SS sheeting
LEAKAGE: There shall not be any leakage found in the chilled water pipeline.
DUST EXTRACTION:
No. OF POINTS: Based on the area requirement
MODE OF EXTRACTION: Negative suction using motor
E] EQUIPMENT: Carry out the following checks on equipment.
CLEANING: The equipment shall be cleaned as per the relevant cleaning SOP.
MAN / MATERIAL MOVEMENT: There shall be adequate space for man and material movement.
INSTALLED EQUIPMENT: The equipment relevant to the operation shall be installed.
F] SAFETY: Carry out the following checks related to Safety.
ACCESSIBILITY TO EMERGENCY DOOR: The emergency door shall be easily accessible in the area. The emergency door shall be marked with a separate label.
ACCESSIBILITY TO FIRE EXTINGUISHER: Fire extinguishers shall be easily accessible in the area with SOP.
ACCESSIBILITY TO FIRST AID BOX: Information regarding the first aid box shall be available in the area.
G] SANITATION
AREA CLEANING: The area shall be thoroughly cleaned as per the relevant SOP.
FUMIGATION: Carry out the fumigation for all critical areas.
Specifications for fumigation: 84 gm. of Potassium permanganate in 0.252 kg of formalin per 1000 cu. ft of area.
AREA SETTLE PLATE: Carry out the area settle plate as per SOP.
Total microbial count: NMT – 100 CFU/ plate
Total fungal count: NMT – 10 CFU /plate
Area Details:
- Walls
- Type:
- Finish
- Painting
- Shade
- Ceiling
- Type
- Finish
- Painting
- Shade
- Flooring
- Type
- Jointing
- Finish
- Skirting / Dado
- Type
- Jointing
- Finish
- Coving
- Wall to floor
- Wall-to-wall
- Wall to false ceiling
- Wall to return air riser
- Wall-to-door frame
- Door
- Type
- Dimension (W X H meter)
- No of doors
- Location
- Painting
- No and what type of door closer
- No and type of handle
- No and type Fender
- Size of the glass view panel
- Door interlocking
- Windows
- Type
- No of windows
- Dimensions (W x H meter)
- Jointing
8. Cutouts in the ceiling: Nos. /Finish
- Electrical light fittings:
- Pendants:
- Dust extraction pendants:
- HVAC diffusers
- Return air riser
- Drainage
- Type of trap
- No and location
- Material of construction
- Electrical work
- Wiring type
- No light fittings and type
- Arrangement for emergency light
- No telephone points
- No of the computer points
- Power sockets:
- No single phase sockets & type
- No three-phase sockets & type
- No lighting switch box & type
- Illumination level in Lux
- HVAC system
- No of diffusers
- Specification of diffusers:
- Return
- Supply
- Maximum no of persons
- No of air changes (NLT)
- Temperature [° c]
- Relative humidity % NMT
- Conditioning
- Differential Pressure
- Room ISO class
- Building management system
- Indication box
- Size
- Location
- Indication for pressure
- Indication for temperature
- Indication for humidity
- Door status
- Utility services
Purified water
Process water
Compressed air
- Other facilities
- Fly killer
- Air curtain
- PVC strip door
- SS corner angle
- SS fenders
- Fan
- Safety
- Pass box
REQUALIFICATION CRITERIA: –
Facility validation for the Production Granulation area shall be re-qualified if.
ABBREVIATIONS: –
M2 / Ft2 : Square meter / Square Feet
M3 / Ft3 : Cubic meter / Cubic Feet
W x H: Width X Height
HVAC: Heating, Ventilation, Air Conditioning
NLT: Not Less Than
PVC :Polyvinyl Chloride
ISO: International Standard Organization
REFERENCE: –
Guidelines of the Good Manufacturing Practices, Part 2, Validation.