IQ - 6 TRAY DRYER - Ari Healthcare PVT LTD
IQ - 6 TRAY DRYER - Ari Healthcare PVT LTD
IQ - 6 TRAY DRYER - Ari Healthcare PVT LTD
INSTALLATION QUALIFICATION
PROTOCOL NO. 02
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
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INSTALLATION QUALIFICATION
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
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9.1 Conclusion
9.2 Post-Approval Signatures
10.0 Appendix
10.1 Abbreviations
10.2 List of Documents
PROTOCOL APPROVALCOVER
Name Department Sign / Date
Initiated by: Harshad .k.Panchal Documentation
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2.0 Overview
2.1 Purpose:
Each installed sub component complies with the engineering design and
equipment data sheets/specifications, agreed upon with the manufacturer.
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2.2 Responsibility:
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.
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2.3 Requalification:
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.
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Location :
Location Code:
Floor :
Area :
Room Name :
The Location is shown in the Lay out Drawing attached as Attachment ‘D’
Instructions:
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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.
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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.
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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
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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
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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
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Checked by
(Project) Name Sign. Date
Verified by
(Engineering) Name Sign. Date
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3 Steam Connection NA
4 Compressed air NA
connection
Checked by
(Project) Name Sign. Date
Verified by
Submitted By Stamp Checked By Approved By Stamp
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INSTALLATION QUALIFICATION
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Checked by
(Project) Name Sign. Date
Verified by
Submitted By Stamp Checked By Approved By Stamp
Name
INSTALLATION QUALIFICATION
PROTOCOL NO. 02
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Checked by
(Project) Name Sign. Date
Verified by
(Engineering) Name Sign. Date
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Leveling / Alignment
S.No. Item Description How Verified *
OK / Not OK
1. Check whether machine
aligned and level perfectly
Checked by
(Project) Name Sign. Date
Verified by
(Engineering) Name Sign. Date
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Acceptance Criteria :
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
Acceptance Criteria :
6.2.6 Drawings and documents
Attach a copy of or reference the location of all-relevant drawings and documnets and list
below.
Checked by
(Project) Name Sign. Date
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Verified by
(Engineering) Name Sign. Date
Location
SOPs
Operating
Cleaning
Preventive Maintenance
(Leakages)
Checked by
(Project) Name Sign. Date
Verified by
(Engineering) Name Sign. Date
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Checked by
(Project) Name Sign. Date
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Verified by
(Engineering) Name Sign. Date
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.
________________________________________________________________________
________________________________________________________________________
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9.0 Summary:
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. _________.
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(Manager – Project)
___________________________
(Manager - Engineering)
___________________________
(Manager - Plant)
____________________________
(Sr. Manager – Quality Assurance)
10.0 Appendix
10.1 Abbreviations
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