PQ for Metal Detector - Pharmafan.com

OBJECTIVE of PQ for Metal Detector

To determine that the PQ for Metal Detector perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications under normal condition, and where appropriate the worst case situations

TABLE OF CONTENT

PARTICULARS	PAGE NO.
Table of contents
Objective
Scope
Re-Qualification Schedule
Location of equipment
Validation team & Responsibility
Pre-approval of documents
Scope of supply
Brief Process Description
Re-Performance Qualification Procedure
Performance Verification
Re-Performance Qualification Report
References
Result
Deviation
Conclusion
Recommendations
Attachments
Post approval of document

SCOPE

To be performed after installation, modification or relocation and for the performance at appropriate interval or as per re-qualification planner.

Performance of the sifter machine shall be documented for future reference.

Assure that the metal detector machine performance is adequate to support the process for which the system is intended

RE-QUALIFICATION SCHEDULE

Frequency

Performance check of the machine should be qualify after every 5 years ±2 months and as per requirement.

LOCATION OF EQUIPMENT

The location of the equipment is in compression in manufacturing section.

S. No.	Name of Equipment	ID No.	Room Name
1	Metal detector		Compression

VALIDATION TEAM AND RESPONSIBILITY

Department	Responsibility
Production	Preparation of protocol and compilation of report. Review of protocol and report. Execution of Re-Qualification activities as per the protocol. Responsible for the compliance of Re-qualification data
Engineering	Review of protocol and report. To assist user/concerned department during Re- qualification activity
Quality Control	Review of protocol and report. Responsible for analysis of samples & evaluations of the test results.
Quality Assurance	Review, approval and certification of the protocol / reports. Execution & approved of re-qualification activities as per the protocol & certification after successful re-qualification of the equipment.

PRE APPROVAL OF DOCUMENTS

Prepared by

Designation	Name	Date	Signature
Executive/Officer Production

Checked By

Designation	Name	Date	Signature
Head Engineering
Head Production
Head Quality Control

Approved by

Designation	Name	Date	Signature
Head QA

Scope of Supply:

Description	Specification
Model	GMP Model
Model	External dimension:- (all in mm)
Accessories	Safety cover
Accessories	Adjustable shaft
Control system	220 volts, single phase power supply

PQ for Metal Detector Brief Process Description:

Metal detector is an instrument that detects the nearby presence of metal. Metal detectors are useful for finding metal objects on the surface, underground, and under water. A metal detector consists of a control box, an adjustable shaft, and a variable-shaped pickup coil. Metal detectors work on the principle of transmitting a magnetic field and analyzing a return signal from the target and environment. The transmitted magnetic field varies in time, usually at rates of fairly high-pitched audio signals.

Metal detectors are used in food and pharmaceutical industries to detect metal contamination in products or packets. The metal contamination may occur in food and pharmaceutical products due the presence of metallic pieces or components (viz., fasteners, pins, buds, eroded or corroded metallic parts etc.) in ferrous, non-ferrous, or stainless-steel materials. Detection of such metal contamination is important and in this detection process, high accuracy and reliability are desirable. Thus, a metal detector plays an important role in ensuring product safety. In pharmaceutical industry there is a possibility that the products get contaminated by metallic parts either magnetic or non-magnetic. This is due to metal-object contamination (ingredient contamination, mixing-process errors and machinery failures) and due to the use of various process equipment viz. reactors, agitated and storage vessels, classifiers, dryers, pumps, valves, pipes etc. in the synthesis, processing and storage and most of these equipment, pipes, valves and pumps are made up of metals.
In many pharmaceutical processing, unsaturated organic compounds that contain double and or triple bonds need to be hydrogenated. Platinum black, palladium black, copper metal, copper oxide, nickel oxide, aluminum and other materials have subsequently been developed as hydrogenation catalysts. Abrasive materials can wear mill parts and screens. In these operations, there a probability always exists the products get contaminated with various metallic components. The final food and pharmaceutical products must free from metal contamination as per GMP standards.

Machine rated for continuous operation
Higher output with process uniformity.
All contact parts of SS 316 AISI.
All contact parts can easily be dismantled and cleaned for change of product.
Technical Details:
Outside controls
Design as per stringent cGMP requirements.
All Contact parts of AISI Stainless Steel 316 Quality
All Non contact parts of AISI Stainless Steel 304 Quality
Silicon Food Grade seal/ gasket
Easy mobility
Easy to clean all contact parts

PQ for Metal Detector PROCEDURE

The action of repeating the qualification or reconfirming that process, product or equipment is suitable for a particular position or task.
Availability of product for operates with load to be checked.
The power supply and connected utility was checked before starting re-performance qualification.
The operating functions of switches and buttons were checked before executing the activity.

PERFORMANCE VERIFICATION

Objective of this performance verification is to provide documented evidence that equipment perform as per respective and up to its operating & performance range

Standard Operating Parameters Verification

Objective of this verification is to provide documented evidence that equipment perform satisfactory as per its standard operating procedure.

Cleaning check:

Check points	Observation	Checked By (Sign & Date)
Check the cleanliness of the sifter hopper
Check the cleanliness of sifter ring, sieves and its gasket
Check cleanliness of the sifter body and its wheels
Check the cleanliness of gasket and clamp
Check the cleanliness of discharge chute
Check the cleanliness of sieve

Safety precaution while sifting of material:-

Mask and gloves should be wearing during sifting.

Performance check of the machine/equipment:-

Test	Acceptance Criteria	Observations	Done By Sign/Date	Checked By Sign/Date
Check the machine for proper placement.	Machine should be place in adequate space & there should be enough space
Check the machine for proper vibration for sieving of material.	Machine vibration should be adequate to sieve the material.
Check the uniformity of material on the sieve.	Material should cover all the corners & center on the sieve & pass through all the face area of the sieve.
Check the proper sealing of the clamp with gasket.	Material should not be leak from the clamp sides during operation.

Test Method:

Operate the equipment as per Standard Operating Procedure SOP no. APD/PRD/002 for Operation & Cleaning of Vibro sifter machine and record the performance of the machine.

Testing procedure:

For performance check of the sifter machine, take raw material and pass the material from the minimum, medium & maximum size of sifter sieve.

Take raw material quantity 1 kg of Lactose monohydrate and open the clamp set of the sifter. Sieve of 40# size to be fix in the sifter after fixing of sieve assemble the clamp set and switch on the sifter. Put the material in the hopper using scoop & collect the passed material in labeled poly bag. Weigh the collected material & calculate in the calculation sheet given below.

Testing for average/medium size of granule:-

Take raw material quantity 1 kg of MCCP 102 and open the clamp set of the sifter. Sieve of 60# size to be fix in the sifter after fixing of sieve assemble the clamp set and switch on the sifter. Put the material in the hopper using scoop & collect the passed material in labeled poly bag. Weigh the collected material & calculate in the calculation sheet given below.

Testing for maximum size of granule:-

Take raw material quantity 1 kg of talcum powder and open the clamp set of the sifter. Sieve of 100# size to be fix in the sifter after fixing of sieve assemble the clamp set and switch on the sifter. Put the material in the hopper using scoop & collect the passed material in labeled poly bag. Weigh the collected material & calculate in the calculation sheet given below.

Calculation sheet: – For sieving of minimum, medium & maximum size of mesh

Size of sieve:-

Total weight of sample/material to be pass through the sieve:-

Result (%) = Weight after the sample/material passed through the sieve X 100

Total weight of sample/material to be pass through the sieve

Record the preventive maintenance status of the machine/equipment.

Equipment Name	I.D. No.	Section	Detail of Preventive Maintenance
Equipment Name	I.D. No.	Section	Done on	Due on

Acceptance Criteria:

Equipment/ Machine shall be operating as defined in the standard operating procedure, if differ then record deviation & check the performance of machine.
Difference of the product should not be less than 2% of the total weight of material to be passed through the sieve.
Operation shall be smooth and there should not be any abnormal sound/ noise.

PQ for Metal Detector REPORT:

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

REFERENCES:

SOP No.

In-house

RESULT:

Checked By (Sign & date):________________

DEVIATION/CHANGE CONTROL

Checked By (Sign & date):________________

CONCLUSION: __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Written By (Sign & date):________________

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