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EQUIPMENT/INSTRUMENT CALIBRATION

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Elango Minnoor, Ph.D., M.B.A., Sr. Manager, Quality Control, Biocon Ltd Conclusion Qualification/Calibration are not optional but needed for regulatory compliance A ... – PowerPoint PPT presentation

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Title: EQUIPMENT/INSTRUMENT CALIBRATION


1
EQUIPMENT/INSTRUMENT CALIBRATION
  • Elango Minnoor, Ph.D., M.B.A.,
  • Sr. Manager, Quality Control, Biocon Ltd

2
Agenda
  • Introduction
  • Equipment/Instrument Qualification
  • Equipment/Instrument Calibration
  • Conclusion

3
Equipment/Instrument - Classification
  • All analytical devices can be classified under 2
    categories viz. Equipment and Instrument.

4
Labs Goal - Reliable Results
  • Reliable instruments
  • Buying the right instrument
  • Ensuring its performance (accuracy, precision,
    etc)
  • Validity of analytical methods
  • Proper training of analysts

5
Choosing the Right Instrument
  • Start with Accurate Monitoring Instruments No
    matter how sophisticated the calibration
    procedure is, it cannot compensate for the
    inherent performance limits of the instruments it
    calibrates.
  • No amount of calibration or re-calibration will
    improve the accuracy of an instrument as a
    measuring device.

6
Choosing the Right Instrument - Contd
  • Is the instrument calibration NIST traceable?
  • Tells about the instrument/standard that was used
    for calibration
  • Nothing about the performance of the test
    instrument itself

7
Components of Analytical Instruments
  • The collective analytical measurement
    instruments, in conjunction with firmware,
    assembled to perform a mechanical process.
  • A device or collection of components that perform
    a process to produce a result

8
Instrument Procurement and Life Cycle
9
Why is Qualification Calibration Necessary?
  • Qualification
  • It basically proves that the equipment works
    correctly and actually leads to accurate and
    reliable results
  • Calibration
  • Ensures that on an on-going basis that the
    equipment is performing properly
  • Often times, these tests are sub-set of the
    qualification tests performed

10
Responsibility
  • "Users are ultimately responsible for instrument
    operations and data quality. The user's group
    encompasses analysts, their supervisors,
    instrument specialists and organization
    management.
  • "Users should also be responsible for
    qualifying/calibrating their instruments, because
    their training and expertise in the use of
    instruments make them the best-qualified groups
    to design the instrument test(s) and
    specification(s) necessary for successful AIQ."

11
Classification of instruments
  • Classify instruments into Group A, B and C
  • Group A
  • No measurement capability or requires calibration
  • Mixers, centrifuges, etc
  • Group B
  • Providing measurements or controlling physical
    parameters such as temperature, pressure,etc
  • Balance, thermometer, pH meter
  • Group C
  • Sophisticated instruments such as HPLC, GC, etc

12
Qualification - Four Qs
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

13
Design Qualification
  • Documented collection of activities that defines
    functional and operational specifications/require
    ments
  • Criteria for selecting the vendor
  • Details the conscious decisions of the selection
    of the supplier

14
Design Qualification - URS
  • Define location, shape and area needed
  • Define equipment (shelves, drawer needed?)
  • Define safety and environmental aspects (fire
    detector)
  • Define security requirements (on-line monitoring,
    locking system)
  • Define budget
  • Define basis and scale of qualification

15
Installation Qualification - IQ
  • Establishes that the instrument is delivered as
    designed and specified, that it is properly
    installed in the selected environment, and that
    this environment is suitable for the operation
    and use of the instrument
  • When to do
  • After system reconfiguration
  • -Addition of modules
  • -After system relocation.
  •  

16
Installation Qualification - IQ
  • Requirements
  • Description Provides a description of the
    instrument including all components including
    serial number, hardware version, location, etc
  • Delivery Ensure that all the components, manual
    and spares have arrived as per PO
  • Utility/Facility/Environment Installation site
    meets manufacturers requirement
  • Assembly Installation Assemble, install and do
    preliminary diagnostics
  • Network Data Storage Connect to network and
    check functionality

17
Operational Qualification
  • The goal of this test is to demonstrate that the
    system operates as intended after placement in a
    user's environment
  • OQ verifies key aspects of instrument performance
    without the aspects of any contributory effects
    that could be introduced by a method.
  • Verify that the main operating parametersinjectio
    n volume, flow rate, mobile-phase mixing, column
    thermostating temperature, and detection
    wavelength are within their specified limits for
    accuracy and precision.

18
Performance Qualification - PQ
  • Demonstrate that instrument performs consistently
    as per specifications defined by the user and is
    appropriate for the intended use
  • Requirements
  • Set up experiments to verify the performance of
    the instrument
  • When to do
  • After Preventive Maintenance
  • After major module service
  • After system reconfiguration

19
Calibration Program Quality System
  • System must be in place to ensure that all
    instruments are calibrated and also to prevent
    use of an instrument that is not calibrated,
    unusable due to damage or malfunction, or has
    exceeded its established calibration interval
  • System must be in place that identifies
    instruments that do not require calibration to be
    performed beyond the original or factory
    calibration to distinguish from those instruments
    that do require scheduled calibrations

20
Calibration Frequency
  • manufacturers recommendations
  • relevant procedures sensitive?
  • instrument performance history
  • overall impact of non-compliances in the
    calibration process and previous experience of
    the laboratory technical staff.

21
Unplanned Calibration
  • Unplanned Calibration can be called for
  • When the instrument is physically moved to a
    different location within a lab
  • Questionable or ambiguous results are obtained
    perhaps as a part of investigation

22
Calibration Specification
  • Instrument calibration tolerance limits should be
    established so problems are identified and
    corrected in a timely manner
  • When assigning tolerances, considerations given
    to
  • Capability of the instrument being calibrated
    (what the manufacturer claims the instrument can
    achieve).
  • Parameters at which the instrument operates (ex
    if testing accuracy of 0.5 is required, the
    instrument calibration tolerances should be
    lt0.5)
  • Work environment - environmental conditions can
    affect the performance of the instrumentation

23
Success of Calibration
  • Success of calibration depends on the following
  • Consistency of results obtained
  • Recognition and mitigation of outlier/potential
    outliers
  • Scientifically designed calibration frequency

24
Calibration Quality System
  • Specific Directions
  • Schedules
  • Limits of accuracy precision
  • Remedial Actions
  • Systems to prevent usage of instruments failing
    calibration

25
Tracking Instruments for Calibration Status
  • Each instrument given a unique identifier
  • Instrumentation details associated with this
    number must be documented and available (e.g.
    serial number, model number, location, etc.)
  • Each instrument should be labeled with the unique
    identifier
  • Calibration status of each instrument , the date
    of calibration, the next calibration date and the
    identification of person performing calibration
    should be readily available
  • Appropriate systems to document calibration
    status include calibration logs and calibration
    stickers

26
Calibration Process
  • Written calibration procedures that use traceable
    calibration standards or calibration equipment.
  • Qualified individuals (having the appropriate
    education, training, background and experience)
    responsible for calibrating maintaining
    instrumentation
  • Second person check of all calibration tests
  • Qualified individuals responsible for monitoring
    the calibration
  • Ensure the calibration program and procedures are
    reviewed and approved by Quality

27
Calibration Process - Contd
  • Each calibration maintenance procedure should
    include the following
  • Identification of department responsible to
    perform the calibration or maintenance
  • Step-by-step calibration instructions, reference
    to appropriate calibration procedures or
    instrument manuals
  • Methods for preventive maintenance or reference
    to appropriate instrumentation manuals
  • Calibration equipment used in the calibration are
    valid (e.g. spectroscopy filters, voltmeters,
    digital thermometers, etc)
  • Calibration parameter and tolerance ( )

28
Out-of-Calibration Procedure
  • If calibration is not complete within time.
  • Results from the calibration do no meet set
    criteria.
  • Identification of Causes
  • Training of analyst for calibration procedures.
  • Glassware/Standards Cleanliness, Validity etc.
  • History of malfunction/breakdown and maintenance.
  • Review of previous calibration report.

29
Out-of-Calibration Procedure - Contd
  • Data generated from the successful calibration
    till the next calibration is evaluated for the
    Impact. If Impact analysis reveals suspect
    results, random batches/products are picked up
    and analyzed and results are compared to the ones
    obtained from OOC instrument.
  • If the results are different, then appropriate
    evaluation and justification need to be provided
    (QC/QA).
  • Based on the outcome of the investigation, CAPA
    is implemented and the re-calibration is
    performed.

30
Records for Calibration
  • All calibration records must be retained per
    document retention procedures
  • Should include as found measurements, results
    of adjustments (as left) and appropriate review
    approval of all results
  • Tolerance or limit for each calibration point
  • Identification of standard or test instrument
    used
  • Identification of persons performing the work and
    checking the results with dates

31
After Calibration
  • Review must ensure the approved activities have
    been completed and all results have passed the
    established acceptance criteria
  • Actions to be taken if instrumentation cannot be
    calibrated (e.g. contact appropriate service
    people, label and remove from service)
  • A step to record all calibration maintenance
    activities
  • Periodic review of historic calibration
    maintenance data to evaluate appropriateness of
    established frequencies

32
HPLC Calibration Tests
  • Injection Volume
  • Accuracy
  • Precision
  • Linearity
  • Mobile phase
  • Flow rate precision
  • Accuracy
  • Precision

33
HPLC Calibration Tests - Contd
  • Column Oven
  • Thermostat accuracy
  • Thermostat precision
  • Detectors
  • Wavelength accuracy
  • Response linearity
  • Signal-to-noise ratio

34
Conclusion
  • Qualification/Calibration are not optional but
    needed for regulatory compliance
  • A strong calibration program ensures
  • Highly Efficient Lab
  • Reliable Results
  • Quality Product
  • Patient Safety

35
  • Thank You
  • Any Questions?
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