URS of De-Dusting Machine
Table of Contents
|6.0||Commissioning and Documentation|
|S. No.||Parameters||Required Specifications|
|Portable unit for Tablets de-dusting.|
|The equipment will be used for online removing of dust adhered to the tablets.|
|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
|As per Annexure-1|
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.|
|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.
|·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.
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.|
||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
|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.
Start up support
|Supplier to train the respective technical associates of company on operation, maintenance and cleaning of the equipment wherever applicable.|
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)
|9.||Deviations||Any deviation from URS shall be highlighted.|
|URS||User requirement specifications|
|PLC||Programmable Logic Control|
|NPL||National Physical Laboratory|
|NIST||National Institute of Standards & Technology|
|SCADA||Supervisory Control and Data Acquisition|
|MMI||Man Machine Interface|
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