IQ - 6 TRAY DRYER - Ari Healthcare PVT LTD

TRAY DRYER MEC-WELL
(MODEL: MPM /TD/6 TRAY/GMP ) PHARMA
INSTALLATION QUALIFICATION
PROTOCOL NO. 02
TRAY DRYER -6 TRAYS

CLIENT SUNRISE INTERNATIONAL LABS LTD.

P.O. NO. SILL-102/ DATE:30/05/2016
PLOT NO 100,IDA PHASE-
LOCATION II,CHERLAPALYY,HYDERABAD-500051
MODEL NO. MPM/RMG `/15 LTR/GMP
JOB NO. / SERIAL 1308 /83

NO.
DATE OF MFG. 10/01/2015
Please read and understand the installation, operation and maintenance manual carefully. In case of any doubt
please feel free to write us.
Contents are subject to revision without any notice.
Caution
Failure to comply with the instructions in this manual may result in damage to equipment and personnel.
Office & Factory Address:
MEC-WELL PHARMA MACHINERY CO.
Unit Nos. 28,29, Lucy Industrial Estate, Near Blue Chip,
Opp. Professional Courier,
Sativali, Vasai (E), Thane – 401202, INDIA
Tel: 91-250-6453890, 6453891,
Submitted By Stamp Checked By Approved By Stamp
Sign/Date For Engineering For QA
Name
Company For For SUNRISE INTERNATIONAL labs ltd

Mec well Pharma Machinery co.
Page 1 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
TABLE OF CONTENTS
1.0 Pre-Approval
2.0 Overview
2.1 Purpose
2.2 Responsibility
2.3 Requalification
2.4 System Description
3.0 Equipment Specification

4.0 Equipment Identification
5.0 Equipment Location
6.0 Installation Qualification Procedure
6.1 Inspection Checklist
6.2 Installation Qualification
6.2.1 Major Component Verification

6.2.2 Materials Of Construction (MOC)
6.2.3 Verification of Utility Supply
6.2.4 Identification of Instruments and their Calibration Review
6.2.5 Verification for Installation
6.2.6 Drawings
6.2.7 Standard Operating System (SOPs) Identification
6.2.8 Deficiency (if any) and corrective Action Report
7.0 Acceptance Criteria

8.0 Remarks (if any)
9.0 Summary
Name

Page 2 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
9.1 Conclusion
9.2 Post-Approval Signatures
10.0 Appendix
10.1 Abbreviations
10.2 List of Documents
INSTALLATION QUALIFICATION PROTOCOL
Name of the Equipment : TRAY DRYER 6 TRAYS

Name of the client : SUNRISE INTERNATIONAL
LABS LTD.
Name of Manufacture : MEC-WELL PHARMA

MACHINERY CO.
Unit No. 28,29, Lucy Inds. Estate,
Near Blue Chip,
Sativali, Vasai (E),
Thane: 401 202.
PROTOCOL APPROVALCOVER
Name Department Sign / Date
Initiated by: Harshad .k.Panchal Documentation
Reviewed by: Govind .C.Panchal Design
Approved by: Kanubhai .C.Panchal Marketing & Sales
Name

Page 3 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
2.0 Overview
2.1 Purpose:
The purpose of this protocol is to provide an outline for the Installation

Qualification of equipment for static attributes to verify that:
 Each installed sub component complies with the engineering design and
equipment data sheets/specifications, agreed upon with the manufacturer.
 All supporting utilities are connected.
 All critical Instruments have been identified for calibration.
 The equipment is installed as per the laid down specifications.
 No unauthorized or unrecorded modifications have taken place.
 Required testing reports are available.
 Standard Operating procedures (SOPs) have been identified and listed.
Name

Page 4 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
2.2 Responsibility:
The validation group comprising of a representative from each of the following

departments shall be responsible for the overall compliance with this protocol:
 Project Department
 Engineering Department
 Production Department
 Quality Assurance Department
The Projects and Engineering Department shall be responsible for checking proper
installation and recording installation data as per the procedures outlined in this
protocol.
The Quality Assurance Department shall be responsible for the final review of the
qualification documents and its compliance to meet the acceptance criteria of the
Installation Qualification protocol.
Name

Page 5 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
The summary report shall be approved by the head of Project, Engineering,

Production and Quality Assurance.
2.3 Requalification:
Installation Qualification to be requalified on:
 Replacement of major component of the equipment with a new component.

 Any major modification in the existing equipment.
 Shifting of the equipment from one location to another.
2.4 Heater Description
Heater tray drier is specially designed for drying temperature sensitive or easily
oxidizing material or small batches of expensive products where material loss
must be avoided. The drier body is made out of SS316 2 mm thick fully welded
with covered corners to avoid powder retention after drying and externally it is
buffed to 220 grit mirror finish. The insulation of 75mm thick glass wool with
100kg/m3 density is provided. The heating medium, are the electrical heater fixed
at one end of the machinery..The material to be dried is placed in SS trays . The
trays are of SS316 18 gauge with flat surfaced bottom to ensure good heat
transfer.
2.5 Technical specifications
Equipment tag no MPM/TD/2016/5

Capacity 22 kgs
Model GMP
No of trays 6
Name

Page 6 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
Dimension of dryer 1125mm L x 630mm D x 1050 mm H

Internal dimension 600 mm L x 430 mm D x 480 mm H
No of doors 1 Nos.
Mode of Heating ELECTRICAL
No of trolley NA
Temperature Range 100 deg C Max
MOC of tray dryer Internal SS316, 1.6 mm thick fully welded
with covered corners to avoid powder retention
after drying.
External--- Buffed to 220 grit mirror finish SS304 2 mm
thick in single piece design Buffed to 150 grit
satin finish.
Door External SS304 and internal of SS 316
Sealing Door lips having Pharma grade silicon gasket.
Locking Spring loaded ball latches with suitable
Pressure.
Filters Inlet filter consist of 5 microns microvee
filter.
Damper Infinitely controlled manually damper provided
at the outlet.
Insulation 75mm thick glass wool with 100 kg/m3
density.
CFM 300 CFM
Motor 0.5 HP 1380 RPM 1 Nos.
Name

Page 7 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
3.0 Equipment Specification
Detailed Equipment Specification for Machine No. 59 is mentioned in the Manual

of Tray Dryer 6.
Attachment ‘B’
4.0 Equipment Identification
The subjected equipment is identified as
Model No. MPM/TD 61 Machine No61. (Given by manufacturer)
In-house Tag No.1180 (To be given by M/s. -------)
Name of the Supplier Mec-Well Pharma Engineers
Purchase Order No.

.
The major components of the Equipment are identified as:
 All major assemblies of the tray dryer is mentioned in the operational

and instruction manual.
Name

Page 8 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
5.0 Equipment Location:
Location :
Location Code:
Floor :
Area :
Room Name :
The Location is shown in the Lay out Drawing attached as Attachment ‘D’
6.0 Installation Qualification Procedure
6.1 Inspection Checklist
Instructions:
Name

Page 9 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.1.1 Identify the critical components of equipment and verify that the components are
complying as per desired specifications. Record the observations in the Data
Sheet of section 6.2.1.
6.1.2 Check the MOC of the component as per the instruction mentioned in the section
6.2.2.1. Record the observation of the MOC in the Data Sheet of section 6.2.2.
6.1.3 Identify the utility supplies required for equipment operation. Verify that utilities
are as per the specification mentioned in the Check Point 6.2.3. Record the
observation in the Data Sheet of section 6.2.3
6.1.4 Identify the critical instruments supplied with the equipment or installed on the
utility supply line. Verify that instruments are as per the desired specifications.
Review the calibration status of the instruments. Record the availability of the
calibration record provided by the supplier. Record the observation in Data Sheet
of section 6.2.4.
6.1.5 Check the installation of equipment :
 To Verify the location of installation as per the equipment layout attached as
Attachment No. ‘D’.
 To verify the proper assembly of the components as per the equipment
drawings attached as Attachment No. ‘A’. Record the installation location
and verification of assembly in Test Data section 6.2.5.1.
 To check the leveling and alignment as per the procedure given in the section
6.2.5.3. Record the observation in the Data Sheet of section 6.2.5.2.
Name

Page 10 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.1.6 List the available drawing and record the Ref. No. for their location /availability
in the format under section 6.2.6.
6.1.7 Identify the SOPs and assign SOP Numbers, record the SOP Title and Number in
Section No. 6.2.7.
6.1.8 Record the deficiency (if any) in section number 6.2.8 and report the details of
action taken.
Note:
1. Record all the observations against the respective specifications, mentioned in the
specific check points, under section 6.2 (The specifications are extracted from the
Purchase order / Manual / Manufacturer’s Recommendations).
2. Wherever specifications are not mentioned, record the observations as per the
statement of the data sheet.
3. Incase of non-compliance, give the explanation / justification in the deviation format
under section 6.2.8.
4. When more than one unit of the same type exist, replicate the corresponding data
sheet to match and uniquely identify each page.
5. Incase of multiple options, clearly identify the one, which has been supplied.
6. The calibration certificates of the instruments shall be traceable to
National/International standards.
7. Define all technical terms and abbreviations in the appendix under section 10.0.
Name

Page 11 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.2 Installation Qualification
6.2.1 Major Component Verification

Objective: - To verify that major components as identified below are complying
as per the desired specifications.
S. No. Particulars Specifications

1. Blower
Make Mecwell pharma
CFM 300 CFM
MOC SS316
Type 8” dia, 3 blades, axial flow
Qty 1 nos
2. Motor
Make HINDUSTAN
RPM 1380
Frame 71
SR.NO 0506 H 428469
3 Temperature
indicator cum
controller
Make
Type Digital-ON/OFF type,
Model no TC513A/TC513AX
Range 0-150 deg C
Accuracy +/- 1 deg C
Name

Page 12 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02

4 Sensors
TYPE HEAD
MODEL PT 100
Size 6 mm Dia, 100 mm long, ½” BSP
4 Steam Control Valve NA

Make
Type
5 Steam Radiator NA
Make
Capacity
6 Filters
Make MAP FILTER
Size 6’X 9’ X 50
MICRON 0.5
TYPE FLENGH
MOC ALUMINUM
7 Dampers
Make Mec-Well Pharma
Type Infinetly controlled manual
damper
8 Pressure Guage
Make NA
Name

Page 13 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02

Size NA
Range NA
Qty NA
9 HITER
Make RISHINA
Type U TYPE AIR HITER
KW 0.5
Qty 6 nos
10 Timer
Make selectron
Range 999 min
Qty 1 no.
model Xt 546
SR NO 1112 M 12-068
12 GASKET
MAKE VIJAY RUBEER
TYPE “D” TYPE HOLE
MOC SILICON
QTY 1
Checked by
(Project) Name Sign. Date
Verified by
(Engineering Name Sign. Date
Name

Page 14 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.2.2 Materials of Construction (MOC)
Item Description Specification Observation

Base Frame SS
Gasket Rubber
Insulation Glass Wool
Bottom sheet SS316
Outer sheet SS 304
Inner sheet SS316L
Door SS304
Door handle SS304
I bolt & wing nut handle SS304
Hinges SS304
Electrical coil SS316L
Fan SS316
Motor Guard SS304
Checked by
Verified by
(Engineering) Name Sign. Date
Name

Page 15 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.2.3 Verification of Utility Supply
Objective: - To verify that necessary utility supplies required for equipment

operation are as per the desired specification and connected properly.
S. Utility Specifications Observations Connected

No. and
Identified
(Yes / No)
1. Power Input 410V, 3PH, 50Hz
2. Total Power Approx 8HP

Consumption
3 Steam Connection NA
4 Compressed air NA
connection
Checked by
Verified by
Name

Page 16 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.2.4 Identification of Instruments and their Calibration Review
S. Name of the Instrument Specifications Observations Calibration

No. Certificate
Provided
Yes/ No
1. PT 100 sensor
2. Timer
3 Temperature Indicator
Checked by
Verified by
Name

Page 17 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
Name

Page 18 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.2.5 Verification for Installation
6.2.5.1 Location and Assembly
S. Test Particulars Specifications Observations Acceptance

No. Yes/No
1. Check that equipment is
installed in the Room
specified in Equipment
Layout
2. Check that assembly of
component are as per the
General Arrangement
Drawing which is given in
manual
3. Check for all components
as per packing list
Checked by
Verified by
Name

Page 19 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.2.5.2 Leveling and alignment
Leveling / Alignment
S.No. Item Description How Verified *
OK / Not OK
1. Check whether machine
aligned and level perfectly
* Refer to the method mentioned under section 6.2.5.3
Checked by
Verified by
Name

Page 20 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.2.5.3 A). Method for checking the Leveling of the Equipment

- Using Spirit Level Indicator
 Place the spirit level indicator at different points on the machine frame.
Acceptance Criteria:
The air bubble of the spirit level indicator shall be observed in the center.
- Using Water Level Indicator
 Place transparent tube filled with water of suitable length at various corners.
Compare the levels of water and align the equipment
Acceptance Criteria :
The water level at both the locations should match with the edges of those
locations, if required should be repeated for other edges of the equipment on same
plane.
B). Method for checking the Alignment
- Dial Indicator Method
 .
 Rotate the shaft slowly by hand.
Name

Page 21 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
The total indicator reading should not be more than 0.305 mm.
- Straight Edge Method
 Place the straight edge along the circumferences of both drivers
6.2.6 Drawings and documents
Attach a copy of or reference the location of all-relevant drawings and documnets and list
below.
S. Title Drawing Date Reference Attached

No. /Document No. Yes / No
No.
1 General arrangement drawing
2 Machine layout
3 Process drawing
4 Room layout
5 Packing List
6 Material Test certificates
7 Warranty Certificate
Checked by
Name

Page 22 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
Verified by
6.2.7 Standard Operating Procedures (SOPs) Identification:
Location
SOPs
Operating
Cleaning
Preventive Maintenance
(Leakages)
Checked by
Verified by
Name

Page 23 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
6.2.8 Deficiency (if any) and Corrective Action Report

If there is no deficiency, then write N. A.
Name

Page 24 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
Description of deficiency and date observed :

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Person, responsible for corrective action and date assigned:

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Corrective actions taken and date conducted :

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Conducted By : ___________________ Approved By : ___________________
Date : ___________________ Date : ___________________
Checked by
Name

Page 25 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
Verified by
7.0 Acceptance Criteria
Installation Qualification shall be considered acceptable when all the conditions

specified in various forms under section 6.0 have been met.
Any deviation from the acceptance criteria of the specific check point shall be
reported and decision should be taken for the rejection, replacement or rectification of
the equipment/component.
8.0 Remarks (if any) :
________________________________________________________________________
________________________________________________________________________
Name

Page 26 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
9.0 Summary:
Checks Observations Remarks

Whether acceptance criteria of the
Yes/No
protocol and Specific check points are
met.
9.1 Conclusion :
Tray drier bearing Mac No.61 Is Not qualifying the installation qualification test as per the
guideline described in this Protocol No. 1180 can Be / Not Be tested for its operational
qualification as per Protocol No. _________.
9.2 Post-Approval Signatures
Name Signature Date

___________________________
Name

Page 27 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
(Manager – Project)
___________________________
(Manager - Engineering)
___________________________
(Manager - Plant)
____________________________
(Sr. Manager – Quality Assurance)
10.0 Appendix
10.1 Abbreviations
Name

Page 28 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
10.2 List of Documents
Name

Page 29 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
1. As mentioned above in the verification sheets
Name

Page 30 of 31
TRAY DRYER MEC-WELL
PROTOCOL NO. 02
Name

Page 31 of 31

IQ - 6 TRAY DRYER - Ari Healthcare PVT LTD

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TRAY DRYER MEC-WELL

(MODEL: MPM /TD/6 TRAY/GMP ) PHARMA

TRAY DRYER -6 TRAYS

CLIENT SUNRISE INTERNATIONAL LABS LTD.

JOB NO. / SERIAL 1308 /83

Sign/Date For Engineering For QA

Company For For SUNRISE INTERNATIONAL labs ltd

3.0 Equipment Specification

6.2.1 Major Component Verification

7.0 Acceptance Criteria

Submitted By Stamp Checked By Approved By Stamp

Sign/Date For Engineering For QA

Company For For SUNRISE INTERNATIONAL labs ltd

INSTALLATION QUALIFICATION PROTOCOL

Name of the Equipment : TRAY DRYER 6 TRAYS

Name of Manufacture : MEC-WELL PHARMA

Reviewed by: Govind .C.Panchal Design

Approved by: Kanubhai .C.Panchal Marketing & Sales

Submitted By Stamp Checked By Approved By Stamp

Sign/Date For Engineering For QA

Company For For SUNRISE INTERNATIONAL labs ltd

The purpose of this protocol is to provide an outline for the Installation

 All supporting utilities are connected.

 All critical Instruments have been identified for calibration.

 The equipment is installed as per the laid down specifications.

 No unauthorized or unrecorded modifications have taken place.

 Required testing reports are available.

 Standard Operating procedures (SOPs) have been identified and listed.

Submitted By Stamp Checked By Approved By Stamp

Sign/Date For Engineering For QA

Company For For SUNRISE INTERNATIONAL labs ltd

The validation group comprising of a representative from each of the following

Submitted By Stamp Checked By Approved By Stamp

Sign/Date For Engineering For QA

Company For For SUNRISE INTERNATIONAL labs ltd

The summary report shall be approved by the head of Project, Engineering,

Installation Qualification to be requalified on:

 Replacement of major component of the equipment with a new component.

2.4 Heater Description

2.5 Technical specifications

Equipment tag no MPM/TD/2016/5

Submitted By Stamp Checked By Approved By Stamp

Sign/Date For Engineering For QA

Company For For SUNRISE INTERNATIONAL labs ltd

Dimension of dryer 1125mm L x 630mm D x 1050 mm H

Submitted By Stamp Checked By Approved By Stamp

Sign/Date For Engineering For QA

Company For For SUNRISE INTERNATIONAL labs ltd

3.0 Equipment Specification

Detailed Equipment Specification for Machine No. 59 is mentioned in the Manual

4.0 Equipment Identification

The subjected equipment is identified as

Model No. MPM/TD 61 Machine No61. (Given by manufacturer)

In-house Tag No.1180 (To be given by M/s. -------)

Name of the Supplier Mec-Well Pharma Engineers

Purchase Order No.

The major components of the Equipment are identified as:

 All major assemblies of the tray dryer is mentioned in the operational

Submitted By Stamp Checked By Approved By Stamp

Sign/Date For Engineering For QA

Company For For SUNRISE INTERNATIONAL labs ltd

5.0 Equipment Location: