PQ Bin Blender

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Effective Date: Review Date:

Protocol No: PQP/PG/TAB/010-00 Page No.: 1 of 12

Performance Qualification Protocol Of  Bin Blender (125 LTR) Equipment ID: PGT/BBL/001

Location: Blending Area Revision index

Revision

Reason of revision

PQP/PG/TAB/010-00

Prepared for 1st Time

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Effective Date: Review Date:

Sr. No.

 NA

Section Title

Protocol No: PQP/PG/TAB/010-00 Page No.: 2 of 12

Page No.

Contents

2

1.0

Protocol Approval

3

2.0

Purpose

4

3.0

Scope

4

4.0

Responsibility

4

5.0

System Description

5

6.0

Operation and Design features

5

7.0

Site of Study

5

8.0

System Pre-Requisite

5

9.0

Tests and Checks

9

10 10..0

Diagram of Blender with Sampling location

10

11.0

Checklist For all test and Checks

11

12.0

Document attached

11

13.0

Non Compliance

11

14.0 14.0

Devi Deviat atiion from rom pre pre def defined ned sp spec eciifica ficattion if any any

11

15.0

Change Control

11

16.0

Abbreviation

12 CONTENT

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Effective Date: Review Date:

Protocol No: PQP/PG/TAB/010-00 Page No.: 3 of 12

1.0   PROTOCOL APPROVAL: This Performance Qualification protocol describes the procedure to be followed to Qualify Bin Blender in manufacturing area of general block (Granulation-I) at Maneesh Pharmaceutical Ltd. Signing of this approval  page of protocol indicates indicates agreement with the the qualification approach approach described in this document. document.  Prepared By: Designation

Name

Signature

Date

Officer/Executive (Quality Assurance)

Reviewed By: Designation

Name

Signature

Date

Name

Signature

Date

Head/Designee Production

Head/Designee Quality control Head/Designee Engineering Executive/Asstt. Manager QA Approved By: Designation

Head (Quality Assurance)

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Effective Date: Review Date:

Protocol No: PQP/PG/TAB/010-00 Page No.: 4 of 12

2.0 Purpose ose

To provide documented evidence that the Equipment is performing as per the parameter defined Operational qualification and that it give result as per the predetermined acceptance criteria.  To demonstrate that the system will operate reproducibly and consistently within its operating range. To confirm the suitability of the Standard Operating Procedures for all routine activities associated with the system. The document also provides the observed and obtained values indicating compliance to the PQ Protocol 3.0 Scope This qualification protocol will define the responsibilities, acceptance criteria, basis of design,

technical specifications (of mechanical components, electrical hardware), list of major brought out parts, utility requirements, safety & GMP features and documentation requirements. 4.0 4.0 Resp Respon onsi sibi bili lity ty

The Qualification group comprising of a representative from each of the following departments, shall be responsible for the overall compliance of this protocol: Departments

Responsibilities 

Quality Assurance/IPQ A Production

 

 

 

Engineering

  

Quality Control  

Preparation, review, approval and compilation of the Performance Qualification Document. Co-ordination with Production and Engineering to carryout activity. Monitoring of Operation Process. Review of Performance Qualification Document. Carry out Performance Qualification. Review of Performance Qualification Document. To co-ordinate and support Performance Qualification Activity. Calibration of Process Instruments.



To ca carry rry out the the analy analysis sis of samp samples les in in accord accordanc ancee Protocol



Review of Performance Qualification Protocol.

with with

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

Effective Date: Review Date:

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Protocol No: PQP/PG/TAB/010-00 Page No.: 5 of 12

5.0 System System Desc Descrip riptio tion n   Bin Blender is designed to process pharmaceutical products in accordance with cGMP principles.

6. 6.0 0

Equipment Name

Bin Blender 

Manufacturer’s Name

JAI MATA ENGINEERING LIMITED

Supplier’s Name

JAI MATA ENGINEERING LIMITED

Equipment ID No.

PGT/BBL/001

Location

Blending area

Capacity

125 liters

Oper Operat atio ion n & Des Desig ign n Feat Featur uree

The blender is special form of free –fall blender. Bin blenders are used wherever the volume of usually availaible availaible containers containers are not sufficient sufficient for batch or given process requires requires a fixed clamped blending container. This equipment is basically an acceleration type mixer where the  powders mixing are subjected to acceleration force created by centrifugal force and gravity. The unique shape of blender obtains the thorough mixing and blending action. It is practical to use this blender without cross contamination 7.0   7.0

Site of Study

  Blending Area 8.0 SYSTEM PRE-REQUISITES: S.No. Description of pre-requisite

01

02

Verify that the IQ/OQ of the Blender has been executed and approved. IQ Protocol Document No.: OQ Protocol Document No.: Verify that the final Operating and Cleaning SOPs has been  prepared and available. available.

Completed (Yes/No)

Checked by (Production) (Sign/Date)

Verified by (QA) (Sign/Date)

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

Effective Date: Review Date:

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Protocol No: PQP/PG/TAB/010-00 Page No.: 6 of 12

  9.0 TESTS AND CHECKS 9.1 VERIFICATION OF RPM AT EMPTY AND LOADED CONDITION EMPTY CONDITION S.No. Instrument

LOADED CONDITION S.No. Instrument

Calibration status

Calibration done on

Calibration due on

Set RPM

Observed RPM

Calibration status

Calibration done on

Calibration due on

Set RPM

Observed RPM

9.2 Mixing Efficiency

To verify the mixing efficiency of the Bin Blender by Blending of the product for pre specified time and then evaluating the collected sample from different location for analysis METHOD

Sifting

Transfer the dispensed material material of Maize starch, MCC, DCP, magnesium stearate, Vit B6 & Colour lake brilliant blue.

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Effective Date: Review Date:

Protocol No: PQP/PG/TAB/010-00 Page No.: 7 of 12

Instrucons:

 

Wear nose mask and hand gloves while handling the materials.

 

Check the Sieve integrity . Sift the materials of MCC 40#, DCP 40#, Magnesium stearate 40#, Vit B6 60# & Colour lake  brilliant blue 60# by using sifter and record in table given below. Sr.

Ingredients

Standard

No.

Dispens ed Qty.

Qty.

Sieve

Sieve

Checked

Size

Integrity

by

in Kg

Before Operation

in Kg

After

Residue

Start End Time Time

  Operation (if any) *

02

MCC

30.000 kg

40#

03

DCP

31.550kg

40#

04

Magnesium stearate

0.200 kg

40#

05

Vit B6

0.250 kg

60#

06

Color Lake brilliant  blue

0.100 kg

60#

Done By :

Start me:

* Residue destroyed by : ________

Date

End time: Date

Blending done in two lots: Lot-I

Batch size=12 kg (Minimum batch size)

1. Wear nose mask and hand gloves while handling the material 2. Load 12 kg of material excep exceptt Magnesium stearate in blender blender and blend for 20 minute minute at 10 RPM.

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Effective Date: Review Date:

Protocol No: PQP/PG/TAB/010-00 Page No.: 8 of 12

PRE-MIXING

Parameter

Specification

Pre mixing

20 min

Blender RPM

10 RPM

Observed

Checked by

Verified by

 

LUBRICATION 1. Add magnesium stearte (0.039 kg) to the above step and mixing done for 3 minute minute at 10 RPM.  Parameter

Specifcaon

Pre mixing

3 min

Blender RPM

10 RPM

Lot-II

Observed

Checked by

Verifed by

Batch size=50 kg (Maximum batch size)

1. Wear nose mask and hand gloves while handling the material 2. Load 50 kg of material except Magnesium stearate in blender and bl blend end for 20 minute at 10 RPM.

PRE-MIXING Parameter

Specifcaon

Pre mixing

20 min

Blender RPM

10 RPM

 

LUBRICATION

Observed

Checked by

Verifed by

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Effective Date: Review Date:

Protocol No: PQP/PG/TAB/010-00 Page No.: 9 of 12

1. Add magnesium stearte (0.160 kg) to the above step and mixing done or 3 min minute ute at 10 RPM. Parameter

Specifcaon

Pre mixing

3 min

Blender RPM

10 RPM

Observed

Checked by

Verifed by

Collect the sample from top, middle & bottom approximate 2gm from each location as per sampling location mention in step no. 12 and one composite sample approximately 40 gm. The collected sample were analysed for API (VIT B6) uniformity.  The above procedure with different batch size (12 kg & 5 50 0 kg) was followed so as to get minimum and maximum occupancy level in bin blender. ACCEPTANCE CRITERIA

Assay of all samples should be in between 90-110% RSD should not be more than 5%.

10 10.0 .0 Schema Sch emati ticc Di Diag agra ram m of Blen Blende derr with with samp sampli ling ng lo loca cati tion onss

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

Effective Date: Review Date:

Sample point

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Protocol No: PQP/PG/TAB/010-00 Page No.: 10 of 12

Location of sample

Justification for selection of sample

Verification by test

For verification of Blend uniformity and proper mixing of material at top layer at four corners.

Blend uniformity

U2 U3 U4 Middle Layer M5 M6 M7 M8 M9

Rear Left Rear Right Front Left Front Right Middle Rear side Middle right side Middle front side Middle left side Middle centre

For verification of Blend uniformity and proper mixing of material in blender  which covers rear side, front side, left side, right side and middle of blender 5 locations are selected.

Blend uniformity

Bottom Layer B10

Bottom Centre

Blend uniformity Bottom of blender are conical in shape there for one location is selected for   bottom centre. Pooled sample of all Assay locations

Top Layer U1

Composite

Pooled sample of all locations

11.0 CHECKLIST OF ALL TESTS AND CHECKS Acceptance Criteria

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

Effective Date: Review Date:

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

Protocol No: PQP/PG/TAB/010-00 Page No.: 11 of 12

Assay of all samples should be in between 90-110%. Test Material/Equipment

Calibrated Stop Watch for measuring Mixing time & RPM.

12.0 DOCUMENTS ATTACHED:

• Calibration Certificate • QC Raw Data

13.0 NON COMPLIANCE:

• In case of any deviation observed during PQ, inform to Head QA for necessary action. • Document the deviation detail in observed deviation section. • The Head QA shall study the impact of deviation. If deviation is acceptable and it does not have an impact on operation as well as on performance of the machine, prepare final conclusion.

14.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:

All deviations, non conformances and out of specification results obtained shall be investigated investigated in accordance with corresponding SOPs and documented in the requalification requalification report. 15.0 CHANGE CONTROL, IF ANY:

Details of change controls initiated during the qualification activity, shall be documented in the qualification qualificati on report

 

MANEESH PHARMACEUTICAL LTD. Factory: Unit 6, Village Balyana, Purgana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan. H.P.

Effective Date: Review Date:

PERFORMANCE QUALIFICATION PROTOCOL FOR  BIN BLENDER (125 L) (GENERAL BLOCK)

16.0 ABBREVIATION:  No. : Number WHO : World Health Organization FDA : Food and Drug Administration CFR : Code of Federal Regulations cGMP: current Good Manufacturing Practices RSD : Relative standard Deviation QA : Quality Assurance PQ : Performance Qualification RPM: Rotation per minute VIT: Vitamin  

Protocol No: PQP/PG/TAB/010-00 Page No.: 12 of 12