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URS of De-Dusting Machine

URS of De-Dusting Machine

S. No.

Table of Contents

1.0 General
2.0 Salient Features
3.0 Operational Requirements
4.0 Utilities
5.0 Maintenance
6.0 Commissioning and Documentation
7.0 Training
8.0 Packaging
9.0 Deviations
10.0 Delivery

TECHNICAL 

S. No. Parameters Required Specifications
1.

1.1

General

Equipment No.

1.2

Description

Portable unit for Tablets de-dusting.
1.3

Use

The equipment will be used for online removing of dust adhered to the tablets.
1.4

 

Field Identification

To be installed in Compression area.

Allocated floor space for the equipment to be specified by supplier.

(i)       Room Temperature NMT 300C and RH less than 60%

(ii)     Non flame proof area

1.5
Glossary
As per Annexure-1
2.

2.1

Salient Features

General

2.2
Material of Construction
All the contact parts should be of SS 316 and non-contact parts shall be of SS 304.
2.3 Electrical Construction Non flameproof.
3.

Operational requirement

The system shall operate with a minimum of operator involvement.  Operation shall be safe from an operator and environmental standpoint. The system shall be operated locally at the equipment itself.

·Height of machine (Supplier to specify).

·Control panel shall contain ON and OFF switches.

3.1

 

Control Parameters

·Vibration of the machine shall be adjustable.

·Working height of the machine shall be adjustable.

·Machine shall have provision to connect with Dust Extraction System.

·Machine shall have dust collection box.

3.2

 

Power failure / recovery

In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity and shall not require operator intervention to re-start.
4. Utilities To provide utilities at ONE POINT is user’s responsibility.
5. Maintenance

Supplier should provide the following maintenance instructions,

i.      Operation and Maintenance manuals along with as built drawings

ii.    Daily checks on machine

iii.  Cleaning procedures

6.

 

 

 

Commissioning and Documentation

 

 

· IQ/OQ/PQ to be completed by the supplier along with company representatives.

· The Supplier to demonstrate the Performance of the machine at site as per agreed terms.

· Exact use in the equipment designed.

· Calibration certificates of all the instruments used having traceability to NPL / NIST.

·Performance certificates of Tests conducted.

· At manufacturers end for Motors / Gear Box / Fan and other critical bought out items with Serial nos.

7.

 

7.1

Training

 

Start up support
Supplier to train the respective technical associates of company on operation, maintenance and cleaning of the equipment wherever applicable.
7.2
Post start up support
Telephone / Fax / E mail ID / Address

Replacement parts availability list (normal lead times shall be listed)

System improvements (supplier shall notify user of any improvements)

8. Packaging
9. Deviations Any deviation from URS shall be highlighted.
10. Delivery Company adress

Annexure-1

GLOSSARY

URS User requirement specifications
DQ Design Qualification
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
0C Degree Celsius
PLC Programmable Logic Control
RH Relative Humidity
Pa Pascals
NPL National Physical Laboratory
NIST National Institute of Standards & Technology
MS Microsoft
SCADA Supervisory Control and Data Acquisition
SS Stainless Steel
MMI Man Machine Interface

 

 

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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