PQ for Disintegration Test Apparatus (DT)

Objective of PQ for Disintegration Test Apparatus (DT)

To carry out the performance qualification of the PQ for Disintegration Test Apparatus (DT) as per approved protocols

The scope of this document is to confirm that the design, implementation and operation of the DT apparatus, meet its design intention, specifications and operational requirements. This document details the dynamic attributes of the instrument, and provides evidences of DT apparatus, is operated as per the specification.

TABLE OF CONTENT

Particulars	Page No.
Title page
Table of contents
Objective
Project background & system description
Test assumption and limitations
Validation team and responsibility
Pre-approval of documents
Validation strategy
Qualification procedure
References
Acceptance criteria
Result
Deviation
Summary
Conclusion
Recommendations
Attachments
Post-approval of documents

Validation Team And Responsibility

Department	Responsibility
Quality Assurance	v Preparation of protocol and compilation of report. v Review, approval and certification of the protocol/ reports. v Execution & approval of qualification activities as per the protocol & certification after successful qualification of equipment.
Production	v Review of protocol and report. v Execution of qualification activities as per the protocol v Responsible for the compliance of qualification data
Quality Control	v Review of protocol and report. v Responsible for analysis of samples & evaluations of the test results.
Engineering	v Review of protocol and report. v Execution of Qualification activities with the user/ concern department as per the protocol.

Pre Approval Of Documents

Prepared by

Designation	Name	Date	Signature
Executive/Officer QA

Reviewed By

Designation	Name	Date	Signature
Head Engineering
Head Production

Approved by

Designation	Name	Date	Signature
Head QA

Validation strategy

Brief Process Description:

Disintegration testers work by raising and lowering a ‘basket’ in and out of the test medium, for a set period of time, to see if the tablet dissolves or not. The test medium sits inside the vessel, which sits inside a bath of warmed water, used to replicate the temperature of the human body. The apparatus consists of a basket-rack assembly, a 1-liter beaker, a thermostatic arrangement for heating the fluid and a mechanical device for raising and lowering the basket in the immersion fluid at a constant frequency rate.

PQ for Disintegration Test Apparatus (DT) Procedure

The Performance Qualification status of the equipment shall be checked and the execution shall only be started only after complete execution of operational qualification report.

Availability of product for operate with load shall checked.

The power supply and connected utility shall be checked before starting performance qualification.

The operating functions of control panel switches and buttons shall be checked.

Performance Verification

Objective of this performance verification is to provide documented evidence that equipment perform as per respective and up to its operating & performance range.

Standard Operating Parameters Verification

Objective: Objective of this verification is to provide documented evidence that equipment perform satisfactory as per its standard operating procedure.

Cleaning check:

Check points	Observation	Checked By (Sign & Date)
Check the cleanliness of the equipment.
Check the cleanliness of the internal & external surface of the equipment.

Safety precaution while operating of DT apparatus:-

Mask and gloves shall be wear during operation.

Performance check of the machine/equipment:-

Test		Acceptance Criteria		Observations	Done By Sign/Date	Checked By Sign/Date
Check the equipment or proper placement.		Equipment should be place in adequate space & there should be enough space
Check the equipment or abnormal noise/ vibration.		There should not be any abnormal noise/vibration
Check the proper moving of the all moving parts.		All moving parts should be move smoothly.
Check the water level in the water bath.		Water level shall be up to the water mark.
Check the volume of the fluid in the vessel is such that at the highest point of the upward stroke,		The wire mesh remains at least 15 mm below the surface of the fluid
Check the volume of the water in the beaker to downward stroke.		The wire mesh remains NLT 25 mm from the bottom of the vessel.
Count of the cycles of up & down of the basket assembly per minute.		Cycle per minute shall be 28 to 32.
Check the temperature of water in the beaker.		It shall be 37⁰C±2⁰C.
Check the temperature of water in the bath.		It shall be 37⁰C±2⁰C.
Check the instrument timer for accuracy.	15 min.		It shall not more than ±20 sec.
	30 min.
	60 min.
Check the stroke length upward and downward.			It shall be 53 to 57 mm.

Test Method:

Testing procedure:

Equipment shall be operating as per the standard operating procedure for operation and cleaning of DT Apparatus SOP.

Record the details of the batch passed through the DT Apparatus.

Product Name	Batch Number	Observation	Checked By	Reviewed By
Product Name	Batch Number	Observation	Checked By

References:

Equipment Qualification & Re-qualification

Acceptance Criteria:

Equipment should be operating as defined in the standard operating procedure, if differ then record deviation & check the performance of equipment.

Equipment should properly perform as per the standard requirements.

operation shall be smooth and there should not be any abnormal sound/ noise

Result:

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