JULPHAR GULF INJECT,

GROUP OF COMPANY JEBEL ALI FREE ZONE, DUBAI

USER REQUIREMENT SPECIFICATIONS
Equipment: Isolator for Sterility Testing Department: Quality Control

Written By: QC Analyst Dhruti Pandya URS No.002/QC/2016

Checked By: Syam Perla

Revision No.:00
QA Pharmacist
Approved By: Thangaraj
Issued On:
HOD Quality Control
Authorized By: P.Sineesh
Page: 1 of 7
Plant Manager

1. DESCRIPTION OF FUNCTION
1.1 Shall be compatible for sterility testing.
1.2 Shall comply Class 100 in dynamic condition.
2. REGULATORY REFERENCE:
2.1 Good Practices For Pharmaceutical Microbiology Laboratories.
3. TECHNICAL SPECIFICATION
3.1 Shall ensure the aseptic working environment for testing of pharmaceutical samples for sterility.
3.2 Size of the equipment should be, total length: 1.5 M, total height: NMT 2 M & depth 0.70 M.
3.3 Shall be designed with triple filtration system.

3.3.1.1 Pre filter shall be EU 4.

3.3.1.2 Intermediate filter shall be EU8.
3.3.1.3 HEPA filter shall be EU 14.
3.4 Air exhaust system shall be with HEPA filter.
3.5 All the filters shall be from AAF/Camfil.
3.6 Three numbers of differential pressure gauge shall be provided to monitor the pressure differentials.
3.7 Operating conditions shall be as follows

3.7.1.1 Air cleanliness: ISO Class 5

3.7.1.2 Air velocity : 0.45 +/- 0.05 mps
3.7.1.3 Air flow : Vertical – Re-circulatory
3.7.1.4 Noise level : Should be less than 67 dB

3.8 Shall be able maintain the positive pressure during operation.

3.9 Provision shall be provided to facilitate the isolator integrity testing.
3.10 Working station material of construction shall be SS 316.
3.11 Working station surface finish shall be <0.8 µm Ra.
3.12 Outer surface material of construction shall be SS 304.
3.13 All the materials shall be H2O2 resistant.
3.14 Skin thickness shall be 3 mm.
3.15 Internal covings shall be provided.
3.16 Front screen shall be provided with 12 mm thickness safety glass.
 JULPHAR GULF INJECT,
GROUP OF COMPANY JEBEL ALI FREE ZONE, DUBAI
USER REQUIREMENT SPECIFICATIONS
Equipment: Isolator for Sterility Testing Department: Quality Control

Written By: QC Analyst Dhruti Pandya URS No.002/QC/2016

Checked By: Syam Perla

Revision No.:00
QA Pharmacist
Approved By: Thangaraj
Issued On:
HOD Quality Control
Authorized By: P.Sineesh
Page: 2 of 7
Plant Manager

3.17 Appropriate number of gloves shoulder rings shall be provided.

3.18 Screen shall be able to open upwards with the help of pneumatic cylinders to facilitate sample loading
& unloading.
3.19 Appropriate durable gasket shall be provided for screen sealing.
3.20 Sealing of the front screen shall be monitored by a proximity switch.
3.21 Appropriate number of shoulder rings shall be provided.
3.22 Gloves sleeve shall be transparent.
3.23 Gloves type shall be chlorosulfonated polyethylene & made of Hypalon.
3.24 Gloves size shall be six to seven.
3.25 Glove stretcher shall be provided to facilitate the proper decontamination.
3.26 Operating height of the isolator shall be at least 690 mm.
3.27 Hydrogen peroxide decontamination system shall be integrated with the operating module.
3.28 Day light fluorescent lamp shall be provided.
3.29 Minimum lux shall be 300 lux.
3.30 Statically & dynamically balanced motor blower with suspension shall be provided.
3.31 Working space should be enough to accommodate samples.
3.32 Provision shall be provided for Steritest Equinox.
3.33
3.34
3.35 Digital differential pressure indicator with failure alarm system shall be provided.
3.36 Status indicating light shall be provided.
4. INSTRUMENTATION & CONTROL
4.1 Siemens (S7) PLC shall be provided for the operations & controls.
4.2 MMI shall be provided for the operations & monitoring.
4.3 Ethernet adapter shall be provided for data transfer.
5. OPERATIONAL REQUIREMENT
5.1 Equipment shall be able to perform consistently 24 x 7.
5.2 Particulate cleanliness (Class 100) shall be achieved during dynamic condition.
5.3 Port shall be provided for non-viable particle counter.
5.4 Port shall be provided for the HEPA filter integrity test, preferably in the front side.
 JULPHAR GULF INJECT,
GROUP OF COMPANY JEBEL ALI FREE ZONE, DUBAI
USER REQUIREMENT SPECIFICATIONS
Equipment: Isolator for Sterility Testing Department: Quality Control

Written By: QC Analyst Dhruti Pandya URS No.002/QC/2016

Checked By: Syam Perla

Revision No.:00
QA Pharmacist
Approved By: Thangaraj
Issued On:
HOD Quality Control
Authorized By: P.Sineesh
Page: 3 of 7
Plant Manager

5.5 Provision shall be provided for glove leak detection.

5.6 Service panel should be easily accessible.
6. SYSTEM CONFIGURATION ACCESSORIES, SPARES AND CONSUMABLES
6.1 One set of Gloves sleeve shall be provided.
6.2 One set of door gasket shall be provided.
7. POWER SUPPLY
7.1 Power input to be 220-240 Volt (Single Phase), 50Hz. 380-410 Volt (Three Phase)
8. SAFETY STANDARDS
8.1 Ingress Protection shall be provided for electrical panels.
9. DOCUMENTATIONS
9.1 Design qualification shall be provided.
9.2 Filter certificate shall be provided.
9.3 Material certificate shall be provided.
9.4 List of brought out item shall be provided with suppliers details.
9.5 User shall provide the layout for the verification of equipment fitment.
9.6 All related calibration certificates shall be provided.
10. TEST DOCUMENTS
10.1 FAT should be performed.
10.2 Vendor should arrange FAT documentation.
10.3 Training shall be the responsibility of the supplier.