PERFORMANCE QUALIFICATIONS FOR RAPID MIXER GRANULATOR

by
 Protocol Preparation and Approval

Preparation and Checking:

  Validation Team
Prepared by Checked by
Dept QC QA Stores Stores QC QA
Name            
Signature            
Date            

  Approval: 

  Approved by
Plant Head Head- Quality Control Head- Quality Assurance
Name      
Signature      
Date      

 
 Objective:

  The objective of the protocol is to establish documentary evidence for  the Rapid Mixer Granulator to demonstrate that unit is qualified for correct operation as per guidelines outlined in this protocol.

 Scope:

 This procedure applies to the performance qualification of  Rapid Mixer Granulator Comprising of the following tests

1.                  Air flow laminarity by smoke test

2.                  Non viable particulate count.

3.                  Viable particle count

Responsibility:

1.                  Preparation, Review and approval of the protocol.

2.                  Providing required support during operation and preparation of PQ report.

3.                  Execution of Viable Particle count

Contractor:

1.                  Execution of protocol.

2.                  Collection of data and preparation of final PQ report.

Pre Requisite:          

  1. Installation Qualification Documents
  2. Operation Qualification Documents

References:

United State Pharmacopoeia 29

ISO 14644

EQUIPMENT VALIDATION

The simulation of the process was carried out by connection with the specific machine. Simulation of the process consists of the following: 

Sr. No. Activity Functional Acceptance Criteria Status / Observation
01 HMI operation It should be Smooth touch operation

(with password protection

& recipe management)

  

 

 
02 Impeller Blades Direction It should be clock wise
03 Process Timer Machine should be run as per

set time and then after machine

should be automatically stop.

  

 

 
04 ACVF Drive Speed adjustment & power saver

 PERFORMANCE QUALIFICATION EVALUATION:

 NAME OF PRODUCT:

 PERFORMANCE CRITERIA – BEFORE BLENDING:

1 2 3
MIXING RATIO
ANAYALSIS

PERFORMANCE CRITERIA – AFTER BLENDING:

1 2 3
MIXING RATIO
ANAYALSIS

Performance Qualification Summary and conclusion:

_________________________________________________________________

 

_________________________________________________________________

 

_________________________________________________________________

 

_________________________________________________________________

 

_________________________________________________________________

 Abbreviation 

S. No. Common Term Abbreviation
1 HEPA High Efficiency Particulate Air
2 MG Magnetic Gauge
3 NMT Not More Than
4 OQ Operation Qualification
5 PQ Performance Qualification
6 USP United States Pharmacopoeia
7 ISO International Standard Organization
8 MM Multi-Mill Machine
9 QC Quality Control
10 QA Quality Assurance

Performance Qualification Approval

The performance qualification documents is studied and approved by the Undersigned Authorized Personnel.

The approved Performance Qualification supersedes all the previous agreed specification.

Report Preparation and Review:

 

  Validation Team
Prepared by Checked by
Dept QC QA Stores Stores QC QA
Name            
Signature            
Date            

 Report Approval:

  Approved by
Plant Head Head- Quality Control Head- Quality Assurance
Name      
Signature      
Date