Validation of fluid bed and tray dryer - PowerPoint

							    A
  Seminar
    on
  VALIDATION
      OF
CAPSULE FILLING
   MACHINE




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CONTENT:

 Validation vs Qualification
 Why to validate?

 Who should do Equipment Validation?

 Parts of Equipment Validation

 Validation of capsule filling machine

 References




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VALIDATION vs QUALIFICATION
   VALIDATION
   Action of proving and documenting that any process,
    procedure or method actually and consistently leads to the
    expected results

   QUALIFICATION
   Action of proving and documenting that any premises,
    systems and equipment are properly installed, and/or work
    correctly and lead to the expected results
   The term qualification is normally used for equipment,
    utilities and systems, and validation for processes
     In this sense, qualification is part of validation.
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WHY TO VALIDATE?

Equipment validation is Vital for
 • Safety
 • Fewer interruptions of work
 • Elimination of premature replacement
 • cGMP requirement
 • Reduction of variation in results
 • Greater confidence in the reliability of results

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WHO SHOULD DO EQUIPMENT VALIDATION?
              THE VENDOR OR THE USER?
   The user has the ultimate responsibility for equipment
    qualification.
   DQ should always be done by the user.
   While IQ for a small and low cost instrument is usually
    done by the user, and
    IQ for large, complex and high cost instruments should
    be done by the vendor.
   OQ can be done by either the user or the vendor.
   PQ should always be done by the user

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EQUIPMENT QUALIFICATION
   Equipment qualification / validation includes following
    things :
   User requirements specification (URS)
   Design qualification (DQ)
   Installation qualification (IQ)
   Operational qualification (OQ)
   Performance qualification (PQ)



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  VALIDATION
      OF
CAPSULE FILLING
   MACHINE

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TYPES OF CAPSULE FILLING MACHINE




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CONTROL PARAMETERS FOR HARD
GELATIN CAPSULE FILLING MACHINE




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CONTROL PARAMETERS FOR SOFT
GELATIN CAPSULE FILLING MACHINE




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USER REQUIREMENTS SPECIFICATION
   Basic document that is root for all validation and
    qualification activities
   The goal of working out user requirement specifications is
    to document the needs of the manufacturing department
    A well prepared URS is the key to project success
   Project without detailed URS have a tendency to demand
    lots of change later on thus increase cost and start up time
   For evaluation of URS, the coordinated approach among
    production, QA, engineering units of the pharmaceutical
    company Is required
   Some companies even use the services of external
    resources to create a URS                                  16
Conti…
   The key aspects of any URS is to generate a document
    detailing all the GMP requirements the technical system
    has to fulfill.
   A detail URS will result in a better and more competitive
    offer for the technical system.
   Without comprehensive URS, a pharmaceutical company
    cannot get a clear understanding of supplier and may be
    led to a wrong decision.



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Conti…
    Operational requirements of capsule filling equipment
1.    Operation: Production speed_____capsule per minute
2.    Capsule will be filled to the target weight
     +/-_____%.
3.    The machine shall not experience more than ____%
      downtime at production speed up to, during an eight-hour
      production run
4.    Product contact part: shall be constructed from material
      acceptable to the product
      Certificates for material, weld and finish shall be provided.
      Product contact parts are defined
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Conti…
5.   Power Failure and Recovery: On power failure, the
     system shall fall into a “safe state”.
     On power restoration, the system shall not restart
     without operator or communication-link input
6.   Emergency-stop: buttons shall be supplied within the
     reach of the operator at normal operator stations
7.   Alarms and Warnings:




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   DATA AND SECURITY : Controls provided with a data
    collection system intended for use in the manufacture of
    pharmaceutical products shall comply with 21 CFR, Part
    11 of the FDA cGMP regulations.

   Data Collection:
     Data required for collection
        Machine rate
        Alarms and warnings.
        System status (e.g. “off,” “ on,” “standby” states, etc.)
        Other (specify)                                          21
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    ENVIRONMENT
1.     Physical condition
•    The capsule filler shall be installed in an environment with a
     temperature range of ______ to ______ °Fahrenheit and relative
     humidity range of ______ to _____ %.
•    Vibration levels are:
        Negligible
        Other (specify)
•    Electromagnetic interference levels are:
        Negligible
        Other (specify)
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2.    Cleaning
     The equipment will be cleaned using the following
     compounds/cleaning agents/detergents:
     ______________. It is anticipated the equipment will be
     cleaned on a _____________ basis.




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INSTALLATION QUALIFICATION(IQ)
  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




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Conti…
   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 as per purchase order
   Supplier or manufacturer name & address shall be
    checked
   Any deviation observed should be informed to the
    supplier or manufacturer

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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

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    Conti…
   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




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OPERATIONAL QUALIFICATION (OQ)

   Before initiating OQ ensure that SOP for
    operation and Cleaning of Capsule Filling
    Machine is available.



   Purpose: To train the qualification team for
    performing OQ


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   Procedure
   Check all the dynamic attributes of the capsule filler
    conform to 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 and alarms is
    verified
   Oil leaks that could contaminate the process are
    observed

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   Acceptance criteria
   All operating inputs provided on the equipment when
    tested shall-successfully comply
                 -meet tolerance limit
   The equipment should successfully perform when
    operated as per SOP
   Critical alarm/indicators provided on the equipment-
                --calibrated
   The equipment when operated shall not
        - produce abnormal sound
        - show any discrepancy in its smooth operation.
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PERFORMANCE QUALIFICATION(PQ)
   PQ activities demonstrates and documents that the
    equipment is able to perform its intended functions
    within the variable process limits for a specific product

   Acceptance criteria are developed according
     to the regulatory requirements
     and production parameters

   To ensure that the quality and purity of the product is
    maintained

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Conti…
   The PQ process may also include several challenges to
    the system challenging the operating limits.

   The PQ's require replicate testing; triplicate testing as
    the generally accepted minimum.

   The PQ will also test the extremes of the operation, or
    the peak load conditions, but it does not include testing
    to failure.

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   Procedure
   The accuracy and precision of placebo powder fill will
    be evaluated for each capsule size that will be used in
    normal production
   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                                                 33
REFERENCES
   Berry I.R., and Nash R.A., ”Pharmaceutical
     Process validation” second edition, revised and
     expanded; Marcel Dekker series; 83-110
   www.usvalidation.com
   Syed Imtaiaz Haider, Pharmaceutical
    Master Validation Plan,, st. Luicepress,
    114,119,120.



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