DQ - Autoclave F

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DR.D.Y.

PATILINSTITUTE OFPHARMACEUTICALSCIENCEANDRESEARCH
DESIGNQUALIFICATIONREPORT
Instrument:Autoclave
REPORTNO DYPIPSR/PQA/01/DQ/02 EFFECTIVEDATE 05/02/2024
REF.PROTOCOLNO. DYPIPSR/PQA/2022-23 PAGENO

INSTRUMENT DETAILS

Name of Equipment Autoclave


Location of the Equipment
Equipment Identification No.
Model No
Make
Date of Purchase

TABLE OF CONTENTS

1.0 Objective
2.0 Scope
3.0 Responsibility
4.0 User requirement specification
5.0 FAT Procedure
6.0 Design qualification approval
7.0 Reference documents

1.0 Objectives:
To perform design qualification of Autoclave and assure that the machine is
manufactured as per the URS and it complies with the scope of supply.

2.0 Scope
The scope of this qualification document is limited to the design qualification of
Autoclave . The equipment shall be used for sterilization of Media, glasswares, product
etc.

Prepared By Checked By Approved By


Name &
Designation
Sign&Date
DR.D.Y.PATILINSTITUTE OFPHARMACEUTICALSCIENCEANDRESEARCH
DESIGNQUALIFICATIONREPORT
Instrument:Autoclave
REPORTNO DYPIPSR/PQA/01/DQ/02 EFFECTIVEDATE 05/02/2024
REF.PROTOCOLNO. DYPIPSR/PQA/2022-23 PAGENO

3.0 Responsibility

Name : Signature :

Time : Date :

4.0 USER REQUIREMENT SPECIFICATIONS:

DESCRIPTION SPECIFICATION OBSERVATION

Air purge Automatic, controlled by


microprocessor
Maximum Pressure 1, 5 bar.

Voltage 230 V

Frequency 50/60 Hz

Consume 1000 W

Temperature Adjustable up to 127ºc

Time Adjustable from 0,00 to 99,0


hours

Prepared By Checked By Approved By


Name &
Designation
Sign&Date
DR.D.Y.PATILINSTITUTE OFPHARMACEUTICALSCIENCEANDRESEARCH
DESIGNQUALIFICATIONREPORT
Instrument:Autoclave
REPORTNO DYPIPSR/PQA/01/DQ/02 EFFECTIVEDATE 05/02/2024
REF.PROTOCOLNO. DYPIPSR/PQA/2022-23 PAGENO

5.0 FAT Procedure


After the completion of the erection work of the machine, client shall be informed to
perform the FAT
Client shall perform the FAT at the manufacturer site and record the data in the
prescribed FAT document as per details given below
1. Test criteria
2. Design verification check list
3. Deficiency and corrective action report
4. Pre installation requirement
5. Final report

Prepared By Checked By Approved By


Name &
Designation
Sign&Date
DR.D.Y.PATILINSTITUTE OFPHARMACEUTICALSCIENCEANDRESEARCH
DESIGNQUALIFICATIONREPORT
Instrument:Autoclave
REPORTNO DYPIPSR/PQA/01/DQ/02 EFFECTIVEDATE 05/02/2024
REF.PROTOCOLNO. DYPIPSR/PQA/2022-23 PAGENO

6.0 Design qualification approval :


According to the data collected as a result of this study, the equipment has been properly
designed & qualified in accordance with standards and is now available for process
qualification.

Suppliers Name Position Signature Date

7.0 Reference documents :


1. Manufacturing brochure
2. DQ Protocol No.:

Performed by Validated By Approved By


Signature
Date

Prepared By Checked By Approved By


Name &
Designation
Sign&Date
DR.D.Y.PATILINSTITUTE OFPHARMACEUTICALSCIENCEANDRESEARCH
DESIGNQUALIFICATIONREPORT
Instrument:Autoclave
REPORTNO DYPIPSR/PQA/01/DQ/02 EFFECTIVEDATE 05/02/2024
REF.PROTOCOLNO. DYPIPSR/PQA/2022-23 PAGENO

Prepared By Checked By Approved By


Name &
Designation
Sign&Date

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