RENOWED LIFE SCIENCES

PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

Eqipment Name Cooking Mixing Vessel

Equipment ID RLS/PDC/CKV/002

Capacity 300 kg.

Location Gelatin Melting Room (RLS/ROM/073)

Pre-Approval Date

Post-approval Date

CONTENTS

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

S. NO. TITLE PAGE NO.

1.0 URS Approval 3

2.0 General Information of equipment 4

3.0 Technical requirements 5-7

4.0 Salient Features 8

5.0 Safety Features 9

6.0 Training 9

7.0 Technical Specification 10-11

8.0 Deviation 12

9.0 Delivery 12

1.0 URS APPROVAL:

PROTOCOL PREPARED BY:

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

Department Name Signature Date

Engineering
(Executive/Manager)
Remark :

PROTOCOL REVIEWED BY:

Quality Control
(Executive/Manager)

Remark :

Production
(Executive/Manager)

Remark :

Engineering
(Manager)

Remark :

Quality Assurance
(Executive/Manager)

Remark :

PROTOCOL APPROVED BY:

Managing Director

Remark :

2.0 GENERAL INTRODUCTION & WORKING PRINCIPLE OF COOKING VESSEL (300 KG.):
Cooking vessel (300 kg.) should be main panel for operate the machine.
Machine Drive Motor
2.1 Capsule Conveyor Motor

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

2.2 Hex Roller Motor
2.3 Mangle Roller Motor
2.4 Lubrication Motor
2.5 Tumbler Dryer Motor
2.6 Tumbler Dryer Blowers
2.7 Chiller Indoor Unit Blower Motor
2.8 Chiller outdoor Unit Compressors
2.9 Heater (cartridge)

3.0 TECHNICAL REQUIREMENTS:

3.1 Documentations:
3.1.1 Relevant catalogues and technical details in duplicate to be given with DQ.
3.1.2 Layout showing overall dimensions for each item of Encapsulation Machine and dimensions of
base to be submitted at the earliest for approval.
3.1.3 Power and services requirements for each item of including utility characteristics required.
3.1.4 Certification for critical components.
3.1.5 Shipping weight and crate dimensions.
3.1.6 Safety features.
3.1.7 Change parts requirement, if any.
3.1.8 Complete technical specifications.
3.1.9 All instruments/ gauges/controls including electronic controls should be calibrated and
calibration certificates along with calibration procedure followed to be provided (traceability to
National Standards to be informed by vendor). Vendor should recommend frequency for
calibration of instrument/ gauges/controls.
3.1.10 Certificates for the following should be provided wherever applicable. MOC, Pressure Test,
Performance Test.
3.1.11 Design Qualification (DQ) and General assembly Drawings shall be submitted to us within two
weeks after issuance of Purchase Order. Installation Qualification (IQ), Operational Qualification
(OQ) and Performance Qualification (PQ) shall be done at our end as per the approved Protocol
by Renowed Life Sciences Haridwar.
3.1.12 Operation and maintenance manuals shall be submitted prior to delivery in triplicate, as early as
possible.
3.1.13 All drawings as built to be submitted for records in triplicate.

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

3.1.14 The service requirement shall be clearly indicated. The service hook-up details to be provided.
3.1.15 Commissioning methods and commissioning tests/Qualification/Acceptance criteria shall be
specified either in operational manual or in commissioning document to be submitted prior to
delivery of at the earliest.
3.1.16 Construction certificate shall be provided with the .
3.1.17 Training to operators to be carried out and documented evidence to be submitted.
3.1.18 Details and frequency of Preventive maintenance is to be provided.
3.1.19 Draft SOP for the operation is to be provided before any Qualification activity is under taken.
3.1.20 Recommended cleaning procedure is to be given in the manual. A declaration of hard to clean
area is to be given in the manual.

3.2 Machine Dimensions:

3.2.1 Soft gel encapsulation machine:

Length 1925 mm

Width 1050 mm

Height 2068 mm

Weight 1200 Kg

3.2.2 Tumbler dryer:

Length 2600 mm

Width 1090 mm

Height 1220 mm

Weight 750 Kg

3.2.3 Chiller Indoor Unit:

Length 1890 mm

Width 920 mm

Height 725 mm

Weight 325 Kg

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

3.2.4 Chiller Outdoor Unit:

Length 1005 mm

Width 850 mm

Height 720 mm

Weight 225 Kg

3.3 Utility:
3.3.1 All drive motors to be flameproof suitable for 415 V ± 10%, 3 Phase, 50 ±5% Hz.
3.3.2 All offered should be guaranteed for workmanship and quality of materials for a minimum period
of one year from the date of commissioning.
3.3.3 All system to be provided with overhead relay for protection against single phasing and low
voltage.
3.3.4 All bought out items / Motors /Sub Module should be of reputed make meeting International
Standards.
3.3.5 All system accessories offered should be guaranteed for workmanship and quality of materials
for a minimum period of one year from the date of commissioning.

4.0 SALIENT FEATURES:

4.1 Material of construction of parts in contact with gelatin or medicament:

Encapsulation Machine contact part Material

Spreader Boxes with Gates Brass (Lead free)

Injection Segments Brass (Teflon coated)

Gaskets& O-rings(Segment + Med.
Drinking (potable) water suitable material
Hopper)

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

Shut Off Valve S.S. 410 Hardened & coated

Dosing Tubes Food grade material
Capsulations ( die-rolls) Aluminum alloy extruded
Medicine Hopper/ Manifold S.S.316 or Food grade material Manifold
Medicine Pump centre block K II0 -D2 type
S.S.S 410 Hardened & Tungsten carbide
Medicine pump Plungers
coated
Ribbon casting drums S.S. 316 sleeve on CI casting
Brush Assembly chutes S.S. 316
Synthetic PP (Porous) sleeves on S.S. 316
Lubrication Rollers
rollers
Capsule Conveyor Belt Food grade material

4.2 Material of Construction of non-Critical Parts (not in contact with Gelatin or Medicament)

Encapsulation Machine non-contact part Material

Main Column Cast Iron

Die-roll Housing Cast Iron

Gears EN-9, Brass

Cladding S.S.316/ S.S. 304

Machine Paint Food-grade

5.0 SAFTY FEATURES:

5.1 Emergency Stops provided on H. M. I. Panel & ON Tumbler Dryer.
5.2 MCB‟s (Mechanical Circuit Breakers) for protect the power circuit from any overload condition.
5.3 ELCB‟s (Earth Leakage Circuit Breakers) for Trips with short circuit in panel, Earth leakage, Line
Neutral shorting, Phase-to- phase shorting.

6.0 TRAINING:
6.1 Selected vendor shell provided equipment operational and preventive maintenance training.
6.2 Training Record maintain as per QA SOP.

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

7.0 TECHNICAL SPECIFICATION:

S. NO. ITEM SPECIFICATION
1. Cladding S. S. 316/ S.S. 304
2. Main Column Assembly  Cast Iron structure with gears; most gears are of
alloy steel, some are made of Brass.
 Ribbon casting drums (Hard chrome plated S.S. 316
ring) (Left hand + Right hand).
 Spreader boxes (Lead free virgin brass) (Left hand+
Right hand).
 Two sets of pair of Heaters (750 W each) and one
set of sensors (PT-100) for spreader boxes–(Left

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

hand + Right hand).

 Ribbon rollers – S.S. 316 with porous P.P. sleeves
(to lubricate the Gelatin ribbon)
 Mangle Rollers – serrated and S.S.316 Teflon coated
Mangle Rollers have an independent drive motor.
 Lubrication tank –fill volume 20 liters.
3. Machine Lubrication System
 Lubrication Pump coupled to motor.
 8inch long die-rolls (Aluminum Alloy).
 8 inch segment (Virgin lead free brass) – Teflon
4. Die-roll Housing Assembly coated.
 Brush Assembly/Hex roller assembly has an
independent drive motor
 Medicine pump (6 plungers on each side) having
Tungsten Carbide coating & center block is made of
D2 material.
 Housing of cast iron. With 410 Stainless Steel side
plates having S.S. 316 cladding.
 Dial indicator for pump cradle displacement
5. Medicine Pump Housing indication.
 Digital counter for stroke adjustment indication for
dosing fill volumes.
 Segment Lifting System – pneumatic, with segment
assembly with Heaters (1000 W pair) and sensor
(PT-100).
 Medicament dosing tubes– Food-grade material.
 Food grade material manifold with Sealed tight
6. Medicament Manifold
system to prevent leakage during recirculation.
 Belt of food-grade material.
 Conveyor with Geared motor. Forward/Reverse
7. Capsule transfer conveyor
controls via PLC & with 3 ways switch provided on
motor cover.
 Stainless Steel panel. S.S. 304
 MCB‟s of Siemens make.
8. Control Panel  Allen Bradley PLC –Type Micro Logix- 1400
 Allen Bradley make H.M.I.
 Emergency switch on H.M.I. panel box.

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

 Miniature pumps for each ribbon roller.

9. Ribbon Lubrication System  Tank capacity 5 liters. (2 Nos.)
 ON/OFF Time adjustable through PLC timer.
10. Tumbler Dryer Cladding MOC should S.S. 304
 Drive Motor &Gear box-( Make-Bonfiglioli)
11. Tumbler Dryer
 Blowers– 6nrs.-( Make-ebm-papst)
 Moc Should S.S. 316 Perforated sheeting.
 Size: Dia.560 mm x Width 286 mm
12. Tumbler Dryer baskets
 Capsules are transferred when the flaps are
opened.
 Emergency stop.
13. Tumbler Dryer control  PLC to control drying cycle.
 Auto/Manual control possible.

8.0 DEVIATION:
Any Deviation or Modification to the User requirement specification shall be highlighted .

S. No. Specification Deviation Checked by Verified by

9.0 DELIVERY:
9.1 As per purchase order.
9.2 To be delivered at company address.

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 RENOWED LIFE SCIENCES
PLOT NO-10,11 SEC-6B, I.I.E, SIDCUL HARIDWAR-249403

USER REQUIREMENT SPECIFICATION

Equipment: Cooking Mixing Vessel Equipment No.: RLS/PDC/CKV/002

Document No.: RLS/CKV/URS/002-00 Superseed No.: Nill

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