Академический Документы
Профессиональный Документы
Культура Документы
FOR
MECHANICAL SIFTER
CONTENTS
PRE-APPROVAL
PREPARED BY SIGNATURE DATE
Head of Engineering
Head of Production
POST APPROVAL
PREPARED BY SIGNATURE DATE
Head of Engineering
Head of Production
2. OBJECTIVE
The objective of this Installation Qualification Protocol is to document and qualify the Mechanical Sifter
installed at Idaman Pharma Manufacturing Sdn. Bhd.
3. METHODOLOGY
This Installation Qualification (IQ) protocol will document the result of installation of the Sieving machine.
The protocol and associated report will provide documented evidence for the installation of the Sieving
machine has been installed properly and meets the installation requirement.
4. SCOPE
This protocol will assess the following:
Documentation
Utilities Requirement
Critical Components Feature
Product Contact Part
Installation, Safety and Physical Inspection
.
5. ASSOCIATED DOCUMENT & REFERENCE
1. PIC/S PE009-13, 01 January 2017.
2. ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities, Volume 5,
Commissioning and Qualification, First Edition, March 2001.
3. SOP, S-TCHS-006: Procedure to Perform Qualification for New Facility / System / Equipment
TERM DEFINITION
IQ Installation Qualification
7. RESPONSIBILITY
The following table defines the responsibilities of personnel involved in compilation, execution and
approval of this IQ.
DEPARTMENT RESPONSIBILITIES
Preparation of protocol
Preparation of report
Mechanical Sifter is a circular unitary gyratory screen used to separate mass composition of solids from
solids, liquid from solid and for gradation of materials as per particle size, having a wide range
application. This is accomplished by vibrating the screens in three different planes along the vertical lines
by means of a specially designed vibratory motor having off centered weights at the top and bottom and
of the motor shaft.
The top weight causes vibration in the horizontal plane which causes the material to move across the
screen towards the periphery. The lower weight acts to tilt the machine which causes vibration in the
vertical tangential axis. The angle of lead of the lower weight with relation to the upper weight provides
variable control of the screening pattern. Thus, the material moves across the screens and also in the
vertical and tangential planes enabling maximum screening. This Mechanical Sifter is equipped with
mesh size 16, 20, 40 and 60.
Location Solid Manufacturing
INSTALLATION QUALIFICATION Reference No. IQ 007-18
IDAMAN PHARMA
PROTOCOL
MANUFACTURING Revision No. 00
FOR
SDN BHD Date 02 MAY 2018
MECHANICAL SIFTER
Page No. 8 of 22
Section
Test Description Objective
Reference
Installation, Safety and Physical To inspect and verify the installation, safety and
6.
Inspection physical condition of the equipment.
SS Container
Location Solid Manufacturing
INSTALLATION QUALIFICATION Reference No. IQ 007-18
IDAMAN PHARMA
PROTOCOL
MANUFACTURING Revision No. 00
FOR
SDN BHD Date 02 MAY 2018
MECHANICAL SIFTER
Page No. 9 of 22
10.1.1 OBJECTIVE
To verify that all the lifecycle documentation of the equipment is available and current.
10.1.2 METHOD
10.1.5 RESULTS
Acceptable Verified By
Description Document Reference Result
(Yes / No) (Initial and Date)
Operational Manual
Standard Operating
S-PNTT-015
Procedure:
Operation and Cleaning of
Operation and
Mechanical Sifter
Cleaning
Standard Operating
S-MNEG-064
Procedure:
Preventive Maintenance for
Preventive
Mechanical Sifter
Maintenance
User Requirement
User Requirement Specification for Sieving
Specification (URS) Machine
URS 002-18
Risk Assessment
(FMEA)
COMMENTS:
10.2.1 OBJECTIVE
To verify that critical instrumentation of on the machine have been identified and documented. All critical
instrumentation is calibrated.
10.2.2 METHOD
List the critical instrumentation in the table below; verify all critical instruments are calibrated.
10.2.5 RESULTS
Acceptable Verified By
Equipment Details As Specified Result
(Yes / No) (Initial and Date)
Heater
Control number
Model
Certificate No.
Compressed Air
Meter
Control number
Model
Certificate No.
COMMENTS:
Acceptable Verified By
Equipment Details As Specified Result
(Yes / No) (Initial and Date)
Inlet temperature
Instrument
Control number
Model
Certificate No.
Outlet temperature
Instrument
Control Number
Brand
Certificate No.
COMMENTS:
Acceptable Verified By
Description As Specified Result
(Yes / No) (Initial and Date)
Control System FRL meter
Control No
Cert No.
Control No
Certificate No
Control No
Certificate No
Opening Control
Control No
Certificate No
COMMENTS:
10.3.1 OBJECTIVE
10.3.2 METHOD
Using the table of results, verify all the listed utilities against ‘As Specified’.
10.3.5 RESULTS
Acceptable Verified By
Description As Specified Result
(Yes / No) (Initial and Date)
Electricity
Phase
Ampere
Voltage
Frequency
Compressed Air
COMMENTS:
10.4.1 OBJECTIVE
To verify that all the feature of critical component of the Mechanical Sifter are installed per ‘As
Specified’.
10.4.2 METHOD
Using the following table, inspect and verify all the components features. Record all observation in the
following table.
All critical installed components are installed correctly as per operation manual.
10.4.5 RESULTS
Acceptable Verified By
Description As Specified Result
(Yes / No) (Initial and Date)
Coating Unit
Cabinet
Manufacturer
Coating Pan
Pan Size
Diameter
Pan Mouth
Diameter
Capacity
Drainage
COMMENTS:
Acceptable Verified By
Description As Specified Result
(Yes / No) (Initial and Date)
Driving Unit
Motor
Speed controller
Dimension
Electrical Heater
Fan’s Motor
Dimension
Fan’s Motor
Peristaltic Pump
Brand
Voltage
Serial No.
Stirrer Motor
Brand
Model
Serial No.
Power
COMMENTS:
Acceptable Verified By
Description As Specified Result
(Yes / No) (Initial and Date)
Stirrer Motor Gearbox
Brand
Serial No.
Type
Control System
Model
Brand
Tubing
Model
Brand
Tubing
Opening Control
Model
Brand
Tubing
COMMENTS:
10.5.1 OBJECTIVE
To check product contact parts are made from stainless steel or pharmaceutical grade materials.
10.5.2 METHOD
a. By visual, verify the following product contact parts have been installed against the tank.
b. The product contact parts test by using Molybdenum Test Kit (Avesta - 960).
c. Drop of chemical at Stainless Steel change colour to dark brown (moly present).
316L Stainless Steel change colour from white to dark brown (moly present)
10.5.5 RESULTS
Acceptable Verified By
Description As Specified Result
(Yes / No) (Initial and Date)
Coating Pan
Spray Gun
Peristaltic Pump’s
Tubing
Stirring Rod
Stirrer
Coating Solution
Tank
COMMENTS:
10.6.1 OBJECTIVE
To verify that the suitable type of lubricant to be used thus prolong the equipment shelf life.
10.6.2 METHOD
Using the table of results, verify all the listed attribute against “as specified”.
.
10.6.3 TEST TOOL
10.6.5 RESULTS
Industrial
Gearbox (Stirrer) Gear HD 40 Mobil
Grade
COMMENTS:
10.7.1 OBJECTIVE
To inspect and verify the installation, safety and physical condition of the equipment.
10.7.2 METHOD
Using the table of results, verify all the listed attribute against ‘As Specified’.
All the installation, safety and physical inspection must be inspected and found satisfactory.
10.7.5 RESULTS
Inspection Verified By
Description As Specified
Satisfactory (Initial and Date)
Emergency stop/alarm/interlock
Safety Inspection Yes / No/ NA
installed/ safety door
COMMENTS:
Signatures
Company /
Title Name Date
Department
Full Initials
Location Solid Manufacturing
INSTALLATION QUALIFICATION Reference No. IQ 007-18
IDAMAN PHARMA
PROTOCOL
MANUFACTURING Revision No. 00
FOR
SDN BHD Date 02 MAY 2018
MECHANICAL SIFTER
Page No. 21 of 22
The following table details all Test Incident Reports / non-conformances identified during the execution
of the IQ. All Test Incident Reports / non-conformances identified require the initiation of a Test Incident
Report Form.
Test Corrective
Ref.
Incident Test Incident Report Action Date
Protocol Corrective Action
Report Details Implemented Resolved
Section
No. By:
COMMENTS: