FACILITY QUALIFICATION PROTOCOL STAMP HERE

EQUIPMENT/SYSTEM

PROTOCOL No.

ANNEXURE – XX ROOM DATA SHEET

Room Data Sheet no. : RDS-2DGXXX

Room Name : XYZ Room Room No. : 2DG-XXX
Department : Production Floor : Ground Floor
Observed Checked
Parameter As per design Observation by (Sign/ by (Sign/
Date) Date)
A. Constructional Features
Labelling for the same should be
Room Name & Number
available at outside of each room.
[15390 (L) X 5370 (W) X 5500
Dimension (L x W x H)
(H) mm] + [8170 (L) X 2230 (W)
mm
X 5500 (H) mm]
Volume 554.75 m3
Floor finish PU Base Flooring
82 mm thick PCGI/PCGI clean
Wall
room panel
82 mm thick PCGI/PCGI clean
Ceiling
room panel
Coving between wall and
Coving should be available
ceiling
Coving between wall and
Coving should be available
wall
Coving between wall and
Coving should be available
flooring
No damage (crack/ pinhole/
Damage in room finishing
broken) in room finishing
Location: As per drawing no.
44QS1701/A.01/0045/A0
Type: Solid Filled Metallic
Door location & Quantity powder coated double leaf door
with view panel
Size: 2000 X 2400 mm
Quantity: 01 no.
Are the doors provided
Yes/ No
with door closure systems
Are the doors interlocked Yes/ No

Page 1 of 6
FACILITY QUALIFICATION PROTOCOL
EQUIPMENT/SYSTEM
PROTOCOL No.
ANNEXURE – XX
Parameter
Are doors provided with
locks/ latches.
Window/ View Panel
location & Quantity
Window/ View Panel Type
Damage in doors and
Windows/ View panels
Drain location and
Quantity
Drain Type
Slope towards drain
Clean room status of
Ceiling, walls, floor, doors
& View panels/ windows
(as applicable) #
B. Major Equipment & Utilities
Equipment
Utilities
Utility Piping
STAMP HERE
ROOM DATA SHEET
Observed Checked
As per design Observation by (Sign/ by (Sign/
Date) Date)
Yes/ No
Location: As per drawing no.:
44QS1701/A.01/0013/A0
Size: 1200 x 1100 mm
Quantity: 05 nos.
Solid Filled Metallic powder
coated glazed window
No damage in the doors
Location: As per drawing no.:
44QS1701/C.01/0052/A0
Quantity: 06 nos.
Type: Double Sterile Floor Trap
Quantity: 01 no.
Type: Pressurized Process Drain
Quantity: 04 nos.
Floor should be pitched towards
drain to prevent accumulation of
liquids.
Should comply
CIP System for Skid 1 (4 vessels);
CIP System for Skid 2 (4 vessels)
Chilled Water; Plant Steam; Pure
Steam; Water for Injection (Hot
Loop); Water for Injection (Cold
Loop); Compressed air (Process &
Instrument); Electricity
Piping should be properly labelled
with flow directions
Page 2 of 6
FACILITY QUALIFICATION PROTOCOL
EQUIPMENT/SYSTEM
PROTOCOL No.
ANNEXURE – XX
Parameter
Other fixtures/ furniture
Clean room status of
equipment, fixtures and
utility supply (as
applicable) *
C. Lighting
Switch location, type and
quantity
Power socket location,
type and quantity
Light fixture location, type
and quantity
STAMP HERE
ROOM DATA SHEET
Observed Checked
As per design Observation by (Sign/ by (Sign/
Date) Date)
SS table – 02 nos.; SS Chairs – 02
nos.; Piping cutouts (200 x 200) –
03 nos.
Should comply
Location: As per drawing no.:
44QS1701/E.01/0201/A0
Type: Normal light switch board
with 16A switches (3 Module)
Quantity: 02 nos.
Location: As per drawing no.:
44QS1701/E.01/0210/A0
1. Type: 32A, 240 V, 3 Pin (SPN
+ E) Industrial Metal Clad type
socket outlet with associated
plug top with DP MCB within
Polycarbonate enclosure (On
Raw power)
Quantity: 02 nos.
2. Type: 32A, 415 V, 5 Pin (TPN
+ E) Industrial socket outlet
with associated plug top,
within 4P ELMCB in
Polycarbonate enclosure
Quantity: 01 no.
Location: As per drawing no.:
44QS1701/E.01/0201/A0
1. Type: 3600 Lumens 40W LED
Batten Fixture/ IP20/ Surface/
Ceiling Mounted/ Frosted
Diffuser
Quantity: 09 nos.
2. Type: 3600 Lumens 40W LED
Page 3 of 6
FACILITY QUALIFICATION PROTOCOL STAMP HERE

EQUIPMENT/SYSTEM

PROTOCOL No.

ANNEXURE – XX ROOM DATA SHEET

Observed Checked
Parameter As per design Observation by (Sign/ by (Sign/
Date) Date)
Batten Fixture/ IP20/ Surface/
Ceiling Mounted/ Frosted
Diffuser (Emergency Supply)
Quantity: 02 nos.
Sodium/ Diffuse Lamp
NA
Available
D. Environmental Features
Supplied AHU No. AHU -16

Classification Unclassified
Temperature NMT 30°C
RH NA

Filtration Level G4 & F7

Location: As per drawing no.
44QS1701/A.01/0013/A0
Supply Type: Supply Diffuser (SD2)
Size: 450 X 450 mm
Quantity of
Quantity: 05 nos.
HEPA Filters /
Diffusers/ Risers Location: As per drawing no.
44QS1701/A.01/0013/A0
Return Type: Return Air Diffuser (RD2)
Size: 450 X 450 mm
Quantity: 05 nos.
Proper labelling should be done
Labelling on all supply & return air
diffusers.
Air Changes Per Hour
Min. 8 air changes/ hr.
(ACPH)
Pressure (w.r.t. atm.) 05 Pascal
Provided
Digital Display Unit Type: Temperature & RH
Quantity: 01 No.
E. Safety Features
Emergency Exits Location: As per drawing no.

Page 4 of 6
FACILITY QUALIFICATION PROTOCOL STAMP HERE

EQUIPMENT/SYSTEM

PROTOCOL No.

ANNEXURE – XX ROOM DATA SHEET

Observed Checked
Parameter As per design Observation by (Sign/ by (Sign/
Date) Date)
44QS1701/A.01/0013/A0
Emergency Door
Type: Solid Filled Metallic
Powder coated Emergency Exit
Single leaf door with view panel
and panic push bar (2 hrs. fire
rated)
Size: 1200 x 2100 mm
Quantity: 01 no.
Wall safety railing NA
Breathing Air NA
Eye Wash/ Emergency
NA
Shower
Fire Extinguishers NA
Smoke Detector NA
Oxygen Detector NA
Sprinkler NA
Emergency Light point NA
F. Other Features
LAN 02 nos.
Phone 02 nos.
Digital Clock NA
Speaker NA
CCTV NA
Addressable Manual Call
NA
point
Addressable Loop
NA
Powered Sounder
Addressable type multi-
08 nos.
criteria detector
Access Control NA

Page 5 of 6
 FACILITY QUALIFICATION PROTOCOL STAMP HERE

EQUIPMENT/SYSTEM

PROTOCOL No.

ANNEXURE – XX ROOM DATA SHEET

# Clean room status indicate that construction of ceiling, walls, floor, doors & View panels/ windows, should be free from
seams, cracks or holes (to prevent dirt accumulation and pest entry) and washable, cleanable and free from rust or corrosion.
Walls should be smooth, rigid, and resistant to impact and abrasion. Walls should be easy to clean and resistant to repeated
exposure to disinfectants. Floor-wall joints, building columns, equipment pads and other obstruction should be completely
sealed. Ceiling should be smooth, non-perforated and properly sealed to the framing. Windows/ View panel material should be
durable, washable and cleanable.
* Clean room status indicate that equipment, fixture or utility pipelines should be free from crevices, cleanable and physical
status of the installation should not be damaged and should not shed or accumulate particles. Horizontal or other surfaces on
which dust can accumulate shall be kept to an absolute minimum, and shall be completely avoided in areas where the product
or washed product containers are exposed. Exposed piping and conduit should be avoided as much as possible.
Note: Section A, B, C, E & F shall be verified under Facility Qualification Protocol and Section D –
“Environment Features” shall be verified under HVAC Qualification documents.

Conclusion: _________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________

Concluded by
Department Name Sign/ Date

Engineering

User Department

QA

Page 6 of 6