URS for Sonicator

Objective of URS for Sonicator:    

This document is generating under the authority of the company for the purpose of specifying the user requirement for Sonicator. The URS for Sonicator is provided to define the important components, variables and options necessary for the Supplier to provide a functional of sonicator that meets the needs in the most cost-effective method possible. The URS is also provided to the Supplier to provide a price quote for the supply for sonicator including the design, Performance and manufacture of the equipment.

This URS is an integral part of the procurement agreement with the Supplier.

Approval of Documents:

 Prepared by:-

Name	Designation/Department	Signature	Date

Reviewed by:-

Name	Designation/Department	Signature	Date

Approved by:-

Name	Designation/Department	Signature	Date

Scope:

The scope of this document is to define the requirements of the sonicator in Quality Control lab of company.

Location of equipment:

Machine will be installed in the Quality control department of company

Communication:

References

The supplier shall use the following references in all communications:          –          

Applicable Codes and Standards: –

• The entire Supplier’s work shall comply with all relevant Indian and International Standards and Codes of Practice.
• The Supplier shall confirm all the Standards which have been used for the design and manufacture of the equipment.

System/equipment/Instruments details:

Name of the equipment	Sonicator
Technical Specification	21 CFR
Model/Type	As per GMP model

Scope of Supply:

Type of Device	Sonicator
Machine Standard	The current state of the art GMP Compliance.
Machine design standard for safety	ISO 13850:1996 safety of machinery- Emergency stops principle of design.ISO 14110:1998 safety of machinery- interlocking device associated with guards- principles for design & selection.
Room Condition	Room Temperature: – As per standardRelative humidity: – As per Standard
Features	Design conforming to cGMP standards.
Document & Certificate	Manuals and Maintenance Instructions Operator manualInstallation and assembly instructions for all devices.User’s manuals for all components.Trouble shooting guide.Maintenance Manual.Safety instruction.Training documentation. Electrical and Control diagrams Single line drawing for electrical distribution.Circuit diagramsCable list.Equipment location drawing for electrical equipment and instruments.
Qualification Protocols	IQ Protocol and reportOQ Protocol and reportPQ Protocol and reportVendor should organize for Execution of IQ, OQ and support for PQ
Training	Vendor should impart necessary Operational training to user department and maintenance training to maintenance department.
Test, Calibration, MOC Certification	All test certificate for brought items will be provides during FAT with FAT DocumentsMOC Certificate will be providing during FAT  with FAT documentsCalibration certificate provide for gauge during FAT.

Read Also :- Installation Qualification of Sampling Booth

Brief system description:

• A sonicator is an automated device used to dissolving the solutions prepared in Quality control lab for testing purpose.
• Function:

Sonicators can break down and disperse particles, which is useful in nano technology. . 

• Chiller/Cooling system:

Since sonication generates significant heat, cooling coils or recirculating chillers are used to maintain a stable temperature for sensitive samples. 

• Sound enclosure:

A box that minimizes the loud, irritating noise generated by high-intensity Sonication. 

• Industries:

Sonicator are used in diverse industries like pharmaceuticals, Laboratories etc. 

Technical Specification of URS for Sonicator:

Sr. No.	Particulars	Specification
	Tank Size	(LXWXH) mm
	Capacity
	Time Setting
	Heating Temperature
	Display	LED
	Power Supply	AC 220V
	Lid Material	SS 304
	Electric panel	Electrical panel with push button and digital indicator.Emergency Switch.On/ off switchElectric panel with MCB, contactor, overload relay, controls relay, temperature controller
	Utility Requirement	220 W40 KHz
	Identification	Details of Make, Name, Serial.No., Capacity, Model and Year of manufacture should be available.

Safety Features:

Critical Variables	Acceptance Criteria	Reference
Metal Parts	All the metal parts should be properly grounded without any sharp Edges.	User Manual
Leveling and Balancing	Equipment should be properly balanced & leveled.	User Manual
Installation	All the Installation must be in accordance with the GMP.	User Manual
Electrical Wiring And Earthing	Electrical wiring should be as per approved drawings. Double external Earthing to control machine (panel and motors) and operator should be provided.	User Manual
Noise Level	Below 80 db.	User Manual
Emergency/Safety Switch	Provided easy access position	User Manual

List of Abbreviations.

URS	User Requirement Specification
ENG	Engineering
MOC	Management of change
FAT	Factory Acceptance Test
QA	Quality Assurance
cGMP	Current Good manufacturing
Ltr	Litre