REVERSE LAMINAR AIR FLOW UNIT

1.0 APPROVAL

Function Name Designation Department Signature Date

Prepared by

Reviewed by

Reviewed by

Function Name Designation Department Signature Date

Reviewed by

Reviewed by

Approved by

2.0 REVISION HISTORY

Version Effective Date Revision Summary

P0 10/05/2022 First Draft

3.0 INTRODUCTION
The new facility comprises of, two OSD packing lines, one POD packing line & injectable packing
line. The new facility will have QC laboratory, warehouse & Admin area. The reverse laminar air
flow (RLAF) unit is required to install in the sampling & dispensing area in the new facility.
Specifications for the RLAF required are listed in this document.

4.0 ABBREVIATIONS
Ann Annexure
Bar (g) Gauge pressure in bar
CE Common European Standards
cGMP Current Good Manufacturing Practices
Doc. Document
DQ Design Qualification
Equip. Equipment
FAT Factory Acceptance Test
FDA Food and Drug administration
HEPA High Efficiency Particulate Air
HZ Hertz
IQ Installation Qualification
MOC Material of Construction
NA Not Applicable
OQ Operational Qualification
Ph Phase
QA Quality Assurance.
 USER REQUIREMENT
SPECIFICATIONS

REVERSE LAMINAR AIR

FLOW UNIT

5.0 REQUIREMENTS SPECIFICATIONS

Source of
Sr. No. Parameters Requirement / Specifications
Requirement
Overview
RLAF units are requires for sampling of
URS-1 Use receipt materials & dispensing of approved Process
materials
1400 X 1400 Process
URS-2 Dimensions, mm
1800 X 1600
1400 X 1400: 1 nos Process
URS-3 Quantity
1800 X 1600: 1 nos
URS-4 Flow form Vertically Downwards Process

URS-5 Mounting Floor mounted Process

Background Area
URS-6 Grade D Process
classification
URS-7 Recirculation Type 100% of Air will recirculate within the room. Process
1. HEPA filter (99.999%) (EU 14) shall be
installed in vertical down flow plenum
ceiling for supply air
2. HEPA filter (99.999%) (EU 14) shall be
installed in top front of vertical down
flow plenum for air exhausted to
surrounding environment.
3. 95% efficient high capacity HEPA (EU 7)
filter to be provided in rear return air wall
URS-8 Filter type as an intermediate filter Process
4. Pre-filters (EU 6) shall be installed in rear
return air wall in before intermediate
filter
5. HEPA filter shall be GEL seal type and
shall be loaded from bottom.
6. Filter media shall be micro glass fiber
with hot melt separators, sealed to the
aluminum housing.
7. All filters should be EN 779, EN 1822
certified
Average measured face
URS-9 0.45 m/s ± 20% at working height Process
velocity
1. RLAF shall be able to provide
URS-10 Special features unidirectional laminar flow during Process
operation.
 USER REQUIREMENT
SPECIFICATIONS

Source of
Sr. No. Parameters Requirement / Specifications
Requirement
2. RLAF shall have negative pressure
recirculation air flow design.
3. The design should allow easy cleaning of
the RLAF unit.
4. The RLAF unit shall be provided with in
built light system for operator visibility
and comfort, separate on-off switch shall
be provided for lights
5. The RLAF body should be fully welded
and shall be leakproof for Aerosol to pass
from body to room.
6. The blower speed control nobs shall be
located on the operating panel.
7. Aerosol injection and testing ports shall
be as accessible positions and shall have
minimum distance to filter upstream to
avoid the concentration loss.
8. RLAF shall be supplied with antistatic PVC
strips.PVC strip shall be 6mm thick, 12”
wide with 2” overlap.
9. Two single phase sockets shall be
provided on rear wall for weighing scale
5.1.1 Operating parameters
Parameters to be displayed
1. Differential pressure across the filters
URS-11 on Control Panel & Process
2. Others (vendor to specify)
Monitored
URS-12 Measured Parameters 1. Differential pressure across filters Process

5.1.2 Environment
Process
URS-13 Equipment location & Layout Sampling room & Dispensing room
Process/
URS-14 Electrical classification Safe/Non-Flameproof
Safety
Intended Operating
URS-15 Class A (Background area Grade D) Process
Environment
5.1.3 MOC

URS-16 MOC of Body SS 304 Process

URS-17 Gaskets FDA approved; PTFE enveloped Process

 Source of
Sr. No. Parameters Requirement / Specifications
Requirement
5.1.4 Surface finish
Internal Finish (product
URS-18 NA Process
contact parts)
URS-19 External Finish < 1.2 µm Ra (Matt Finish) Process

5.1.5 Instrumentation and Control

Instrumentation
URS-20 Control panel Microprocessor based
and Control
All necessary safety interlocks and alarms
Instrumentation
URS-21 Interlocks and alarms shall be provided for the safe and trouble-
and Control
free operation of the system
Instrumentation
URS-22 Instruments 1. Magnehelic Gauges
and Control
Parameters settable from Instrumentation
URS-23 1. Air Flow
control panel and Control
Parameters to be displayed 1. System status Instrumentation
URS-24
on control panel 2. Differential pressures across the filters and Control
Instrumentation
URS-25 Accuracy of instruments Vendor to specify
and Control
5.1.6 Electrical/Safety
1. Emergency ON & OFF switch shall be
URS-26 Emergency on/Off provided. Electrical
2. Flush type LED shall be provided with 500
lux level.
Safety/
URS-27 Ingress Protection IP55
Electrical
1. The Fan should have high efficiency EC
Motor
URS-28 Fan and motor 2. The fan supply air flow should be Electrical
automatic control by the use of proper
instrument & control system.
5.1.7 Safety requirements
Power Failure/ Recovery The RLAF units shall be provided with a
URS-29 Safety
methods failsafe shutdown during power failure

URS-30 Noise Level Less than 65 dB (A) Safety

Any other specific safety
URS-31 NA -
requirement
 Source of
Sr. No. Parameters Requirement / Specifications
Requirement
1. All equipment and control wiring shall be
labeled and identified as per current
industry standards. Process/
URS-32 Labeling Safety
2. Tag numbering shall be consistent among
the devices and all corresponding
documentation
All the relevant components used in the
Any other specific
URS-33 system shall be CE certified, and in Projects
requirement
compliance with EU standards.
Utilities / Battery Limits Available

URS-34 Electricity 1Ø , AC 230 V. 50Hz. 3Ø , AC 400 V. 50Hz -

Documentation
Manufacturer should provide (at minimum)
the following documents.
1. MOC certificates
2. Surface finish certificates
3. Confirmatory Certificates for bought out
components.
4. GA drawing along with layout dimensions
5. Design Specifications
6. Fan Curve ,fan selection and certificate
7. IQ & OQ protocols.
URS-35 List of Documents required 8. Operation and Maintenance and service Process/QA
manuals for all components
9. List of bought out items with makes
10. As built drawings
a. Control Schematics
b. Control Panel Assembly drawing
c. Wiring diagrams
11. Spare part list
12. Calibration certificates for all instruments
13. CE confirmatory certificate for all
relevant parts of the machine.
Maintenance

URS-36 Maintenance requirements Maintenance manual to be provided Projects


Sr. No. Parameters
Inspection and Testing
URS-37 FAT & SAT
URS-38 Stage wise Inspection
Commissioning & Validation
Scope of supply
URS-39 commissioning and
validation
Delivery
URS-40 To be delivered at
URS-41 Delivery Schedule
Support
URS-42 Start-up support
URS-43 Ongoing support
Guarantee & Warranty terms
URS-44 Guarantee & Warranty
USER REQUIREMENT
SPECIFICATIONS
Source of
Requirement / Specifications
Requirement
FAT & SAT Protocols shall be shared by
Process
supplier for approval before execution
Preferred /not mandatory Process
1. Design Qualification (DQ)
2. Installation & Installation Qualification
3. Commissioning of the system, including
filter integrity, Particle count, air velocity Projects
testing.
4. Execution of Operation Qualification
Protocols
5. Training to operators
Projects
10 to 12 weeks Projects
Operator training to be included after
Process
commissioning of the system
NA Projects
1. Supplier will be responsible for
replacement at no charge for all faulty
material or defective workmanship for 12
months from date of Installation or 18
months from date of dispatch, whichever
is earlier Projects
2. Process performance guarantee shall be
executed by supplier for performing the
system as per process conditions
indicated in technical specifications of
purchase order.
 USER REQUIREMENT
SPECIFICATIONS

6.0 ANNEXURE / ATTACHMENTS

Sr. No. Title / Description No. of Pages

1. Area Layout 1