Facility Layout and Room Data Sheet (Room Program)

Facility Layout and Room Data Sheet

To develop an effective documentation it is important to know what goes into while designing a GMP Facility. Once we have a know how of designing a GMP Facility and planning which takes place at project stage, we have better understanding of the processes and flows within the facility. Knowledge of these processes and flows gives a direction for development of system and thus preparation of process and quality documents.

A concise flow chart is given below which describe how to design a GMP layout and what is room data sheet. This flow chart in conjunction with the previous post is an introduction to GMP facility design. Detailed information in this field can be obtained from the reference mentioned in the previous post and other engineering and design literature.

Define Manufacturing Process

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Identify volumes to be handled

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Identify major process steps and define the size of the equipments required and total space required for the process

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Make a block diagram of process with equipment sizes and volumes handled. 

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Differentiate the suites / sub suites in which facility has to be divided based on the complexity of the process (refer previous post). Also identify the number of personnel required for each processing step.

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Review the process flow and diagram with experts

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Prepare a Layout considering the following- GMP and Product requirements, Process Flow, Material Flow, Personnel Flow, containment, biosafety level, stage segregation based on cross contamination, Area connectivity, waste material flow, finished product flow, flow of used and fresh garments, decontamination requirements, safety and security considerations (esp. emergency exits).

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Define area classification and differential pressure pattern

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Review the layout with experts (GMP, Clean room/HVAC, Process, Engineering)

Prepare room data sheet (Template provided at the end of this document)

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Finalize the layout as Good for Construction, any changes in the layout or process after this shall be handled through project change management procedure

Room Data Sheet Template:

The room data sheet provides a technical information for each room and can be prepared in Excel sheet. Punch in room number followed by room name or description. There after punch in the technical information column wise as given below:

0.1 ROOM NUMBER
0.2 ROOM NAME/ DESCRIPTION
1.     ROOM INSTALLATIONS
Equipment	Quantity	Capacity/Size	Furniture & Fixture	Quantity	Size of  Furniture & Fixture (mm)
2.     ROOM DIMENSION
L in Mt	W in mt	H in mt	Area Sq Mt	Volume Cu Mt
3.     UTILITIES
N2/CO2/O2	Comp Air	Chilled Water	Industrial Steam	Soft Water	Raw Water
4.     CRITICAL UTILITIES				5.     CLEAN ROOM DRAIN
WFI Cold	WFI Hot	PW	PSG	Floor	Equipment
6.     ELECTRICAL POINTS					-
Industrial		Domestic			-
Phase 1	Phase 3	32 AMP, 3 PH	32 AMP, 1 PH	5/15 AMP	-
ELECTRICAL POINTS UPS			7.     LUMINARIES		-
5 AMP	5/15 AMP	32 AMP 1 PH	18 Watts	36 Watts	-
8.     SECURITY/SAFETY SYSTEM
Data	Voice	CCTV	Access Control	Door Interlocking	Smoke Detector/Fire Alarm
9.     POWER	10.  CLEAN ROOM CLASSIFICATION/PARAMETER
KW	Grade/Class	Diff Pressure	RH	Temp	No of persons

DETAILED HVAC ROOM PROGRAM
1.    ROOM IDENTIFICATION		2.    DIMENSIONAL DETAILS
Room No	Room Name	Room Dimension in mtrs.			Room Dimension in ft.			Room Area in M2	Room Volume in M3	Room Area in Ft2	Room Volume in Ft3
-	-	Length	Width	Height	Length	Width	Height	Area	Volume	Area	Volume
3.    AREA LOAD			4.    HVAC REQUIREMENTS					5.    SYSTEM AIR QUANTITY			-
Eqip. Load	Diversity	Light Load	EU CLASS	Temp. in deg. C	RH in %age	Min. ACPH	Recirculation / 100% Exhaust	Min. Air Flow	Supply	Load	-
KW	%age	W/Sq.ft.	-	+ 2	NMT	Nos.	-	CFM	CFM	TR	-

mm: millimeter, L: Length, W: Width, H: Height, Mt: Meter, Sq Mt: Square meter, CuMt: Meter cube (cubic meter)

N2: Nitrogen, CO2: Carbon Dioxide, O2: Oxygen, Comp: Compressed

WFI: Water for Injection, PW: Purified Water, PSG: Pure Steam Generation

AMP: Amperes, PH: Phase

CCTV: Closed Circuit Television

KW: Kilo Watt, RH: Relative humidity, Temp: Temperature

W/Sq.ft: Watt per square feet, deg C: Degree Celsius

NMT: Not More Than

ACPH: Air Changes Per Hour, CFM: Cubic Feet Per Minute, TR: Ton of Refrigeration