Presented by:-

Machhi Dhruvi A.
2nd sem M.Pharm.

Department of Pharmaceutical Quality Assurance

Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi
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• Capsule filling machine

• Principle of Capsule filling machine
• Construction of Capsule filling machine
• Working of Capsule filling machine
• Qualification of Capsule filling machine
• Installation Qualification
• Operational Qualification
• Performance Qualification
• References

Dhruvi Anilkumar Machhi 25-05-2022

 Capsule Filling Machine 3

Automatic capsule filling machine is a

fully automatic machine, with which
capsule separation, filling and locking
can be done automatically

Dhruvi Anilkumar Machhi 25-05-2022

 Working steps 4

Rectification

Separating caps from empty capsules

Filling the bodies

Scraping the excess powder

Replacing the caps

Sealing the capsules

Cleaning the outside of filled capsule

Dhruvi Anilkumar Machhi 25-05-2022

 Installation Qualification 5

The Installation Qualification will confirm details from

 the engineering specifications
equipment purchase order
cGMP guidelines and requirements
& verify that the equipment has been installed as specified by the vendor

Dhruvi Anilkumar Machhi 25-05-2022

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Purchase Details:
The purchase order no. date shall be checked
The accessories & their spare parts, if any shall be checked as per
purchase order
The delivery period shall be checked as per purchase order
Supplier or manufacturer name & address shall be checked
Any deviation observed should be informed to the supplier or
manufacturer

Dhruvi Anilkumar Machhi 25-05-2022

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Details of the equipment:

Equipment name, make model no. shall be recorded
In-house identification no. shall be recorded
Location for installation shall be checked
Utilities required shall be listed down
A detailed specification must be written which highlight those parts of machine
that are in product contact
Where stirring devices or augers are used to ensure homogeneity and improve
flow then specification of these parts must be checked

Dhruvi Anilkumar Machhi 25-05-2022

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Acceptance Criteria for IQ:

Fulfill the selection criteria & its purpose of application
The equipment shall be as per purchase order
Accessories received shall be as per purchase order
Should meet pre-selected design parameters
Manufacturer/supplier shall provide complete equipment manual
Material of construction shall be as per purchase order

Dhruvi Anilkumar Machhi 25-05-2022

 Operational Qualification 9

• Before initiating OQ ensure that SOP for operation & cleaning of Capsule Filling
Machine is available.
• Purpose is to train the qualification team for performing OQ

Procedure :
Check all the dynamic attributes of the capsule filler meet the required
specifications
Initiate the actual operation of the equipment to ensure that machine is operate
within the desired rate of output.
The operation of indicators, controls & alarms is verified
Oil leaks that could contaminate the process are observed

Dhruvi Anilkumar Machhi 25-05-2022

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Acceptance Criteria:
• All operating inputs provided on the equipment when tested shall
successfully meet tolerance limit
• The equipment should successfully perform when operated as per
SOP
• Critical alarm/indicators provided on the equipment should be
calibrated
• The equipment when operated shall not produce abnormal sound &
shall not show any discrepancy in its smooth operation.

Dhruvi Anilkumar Machhi 25-05-2022

 Performance Qualification 11

Procedure:
Record the number of damaged capsules
Capsules from throughout the lot/different batches should be tested for weight
uniformity
Capsules from throughout the lot/different batches should be tested for blend
content uniformity
Production speed i.e. capsule per minute should be evaluated

Dhruvi Anilkumar Machhi 25-05-2022

 REFERENCES 12

1. http://www.slideshare.net/JadhavAnkushJadhav/qualification-of-
manufacturing-equipments?from_m_app=android
2. Subrahmanyam CVS, Setty JT, Sarasija S & Devi VK in “ Pharmaceutical
Engineering- Principles & Practices”, Vallabh Prakashan, New Delhi, 2001,
390-391, 397-399.
3. http://www.slideshare.net/YashMenghani2/qualification-of-tablet-compression-
machine-capsule-filling-machine?from_m_app=android
4. http://www.slideshare.net/YashMenghani2/qualification-of-tablet-compression-
machine-capsule-filling-machine?from_m_app=android

Dhruvi Anilkumar Machhi 25-05-2022

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Thank you

Dhruvi Anilkumar Machhi 25-05-2022