USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL

USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL

Equipment No’s. 

Description

Use

Field Identification: 

To be installed in medicament preparation room in soft gelatin block.

(i) Room Temperature NMT 25ºC and RH NMT 60 %

(ii)  Non flame proof.

Salient Features

Material of Construction

All the contact parts preferably should be of SS 316L.

Finish: Internal / External –   NLT 220/NLT 180 Grit.

Operational requirements

Capacity: Working Capacity 150 liters.

Control Parameter: Operational at the working pressure up to 1.0 kg. / cm2.

Utilities:

To provide utilities at ONE POINT is user’s responsibility. Supplier to give details and drawings for exact size, location, type, capacity etc. of the utilities required.

Maintenance : 

Supplier should provide (at minimum) the following maintenance instructions,

  • Daily checks on machine
  • Cleaning procedures
  • Documentation : 
  • Layout drawings.
  • MOC certificates.
  • Vendor’s QA certificates at the time of delivery.

Training

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).

Packaging :Shall be describe about shipment packing

Deviations: Any deviation from URS shall be highlighted.

Delivery : Company Address

For more pharma updates details -Please click www.pharmaguidances.com

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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

Check Also

Unlocking Success with User Requirement Specification: Coating Machine URS

Unlocking Success with User Requirement Specification: Coating Machine URS In any project or system development, …