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Performance Qualification of a vial washer

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Although depyrogenation may be achieved using a heating tunnel or oven, if the ... particles, they will produce a pyretic response in humans or animals, although ... – PowerPoint PPT presentation

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Title: Performance Qualification of a vial washer


1
Performance Qualification of a vial washer
2
Contents
  • Introduction-DQ, IQ, OQ, PQ
  • Performance Qualification of a vial washer

3
Introduction
  • DQ(Design Qualification)
  • IQ(Install Qualification)
  • OQ(Operation Qualification)
  • PQ(Performance Qualification)

4
Performance Qualification of a vial washer
  • The importance of PQ for a vial washer
  • Performance of the vial washer should be
    qualified. Although depyrogenation may be
    achieved using a heating tunnel or oven, if the
    washing process cannot remove chemical
    contaminants or particles, they will produce a
    pyretic response in humans or animals, although
    there are no pyrogens present.

5
Performance Qualification of a vial washer
  • The importance of PQ for a vial washer
  • Some drug manufacturers may perform a
    qualitative trace study for coloring matter in
    washed vials using a white wiper to verify the
    performance of the washer, but it is not a
    quantitative method to reflect the actual
    performance of the washer for particles,endotoxin,
    and chemical contaminants.

6
Performance Qualification of a vial washer
  • Provision
  • -21CFR Part 211.94
  • Drug product containers and closures shall be
    clean and, where indicated by the nature of the
    drug, sterilized and processed to remove
    pyrogenic properties to assure that they are
    suitable for their intended use.

7
Performance Qualification of a vial washer
  • Provision
  • -The FDA Guideline for Dosage Form
  • Drug Manufacturers
  • Determine how containers and closures are
    handled and stored.
  • Decide if the cleaning, sterilization, and
    depyrogenization are adequate, and have been
    validated.

8
Performance Qualification of a vial washer
  • A brief description of our vial washer (LIBRA
    HYDRA1000-7-B)
  • Our automatic vial washers (LIBRA
    HYDRA1000-7-B) are designed to wash externally
    and internally many kinds of glass or plastic
    cylindrical containers.
  • There are eight washing stations, plus two
    dripping stations equipped with independent
    connections to their respective circuits to
    prevent cross- contamination among the various
    media.

9
Performance Qualification of a vial washer
  • A brief description of our vial washer (LIBRA
    HYDRA1000-7-B)
  • Each station has seven washing channels.
  • When washing, the needles on each station
    enter the vials as the various media are sprayed.
  • Each washing channel may have a different
    spray strength due to the distance of the spray
    nozzle from the utility supply point.
  • Media spray time can be individually adjusted
    according to bottle size and production speed.

10
Performance Qualification of a vial washer
  • Designing of PQ Study
  • Parameters which will affect the ability of
    the cleaning
  • The ability of cleaning is largely dependent
    on vial size, media spray time, and pressure and
    washing speed.
  • So each size of the vials will be subjected
    to the PQ study.
  • To incorporate the worst case scenario into
    the validation studies, higher washing speed
    (10), shorter media spray time (-10), and
    lower media spray pressure (-10) than the
    pre-established washing cycle will be implemented
    during validation.

11
Performance Qualification of a vial washer
  • Designing of PQ Study
  • whats the purpose of washing?
  • The vial washer is used to clean the drug
    container to eliminate the contamination
    (endotoxin, chemical substance, particles etc.)
    from the container itself to ensure that the
    products produced meet expectations for purity,
    identity, safety, and quality.
  • Thus decontamination studies for endotoxin,
    chemical contaminants, and particles should be
    performed.

12
Performance Qualification of a vial washer
  • Designing of PQ Study
  • whats the purpose of washing?
  • As the internal surface of the vial is
    product-direct contact, a certain quantity of
    each contaminant will be placed into the vials,
    and washed in the vial washer.
  • Then the quantity of contaminants in each
    washed vial will be determined, thus the
    reduction of contaminants can be obtained to
    verify the machine performance.

13
Performance Qualification of a vial washer
  • Questions regarding with the contamination level
    before washing and the acceptance level after
    washing
  • The initial contamination level was obtained by
    testing samples taken from three different
    production lots according to Military Standard
    105E.
  • In this case, for endotoxin, the initial level
    is quite low, and the depyrogenation process of
    dry heat will ensure the endotoxin reduction, so
    we use 1000-10,000EU as the initial level, and
    set acceptance criteria at three log reduction of
    1000EU.

14
Performance Qualification of a vial washer
  • For particle and chemical substance (free
    alkali), we double the data averaged from the
    test results of the initial contamination level
    testing.
  • As any particle or chemical contaminants may
    affect the quality of the products, the
    acceptance criteria should be free of particles
    and chemicals for washed vials.
  • Thus three decontamination studies were
    performed for each kind of vials.

15
Performance Qualification of a vial washer
  • Each study was challenged three times to
    verify the reproducibility of the machines
    performance.
  • Preparation procedures of contaminated testing
    vials for each study and their acceptance
    criteria are listed in Figure 1.

16
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17
Performance Qualification of a vial washer
  • For each study, the quantity of vials to be
    washed is the same as normal production size to
    demonstrate the performance of the normal
    process.
  • Those 280 contaminated vials were divided into
    four groups.
  • The first group is put at the beginning of the
    washing process, the second and third group is
    put in middle of the process randomly, while the
    fourth group is scheduled at the end of the
    washing process.

18
Performance Qualification of a vial washer
  • Each group contained 70 vials in 10 rows, each
    row containing seven contaminated vials washed on
    each washing channel.
  • To ensure each washing channel will be
    challenged and easy to analyze in the case of
    failure, these contaminated testing vials were
    marked consecutively, and deliberately arranged
    as specified in Figure 2.

19
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20
Performance Qualification of a vial washer
  • The washed vials were carefully collected with
    gloves, tweezers, placed into identified,
    particle-free cleaning bags as they exited the
    washer, and sent to the laboratory for testing.
  • As outside contamination will significantly
    affect the test results, special attention was
    required during the collection of the vials.

21
Performance Qualification of a vial washer
  • Laboratory test results for the washed vials
    demonstrated the high efficiency of the machine.
  • Testing vials for particle decontamination
    study were all free of particles and testing
    vials for the chemical decontamination study are
    all free of sodium chloride.
  • Three log endotoxin reductions were achieved
    for each endotoxin decontamination study.
  • Further analysis of the results for residual
    endotoxin demonstrated the performance of the
    vial washer.
  • The average testing results for vials washed
    at different locations show an obvious trend as
    illustrated in Figure 3.

22
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23
Performance Qualification of a vial washer
  • It appears to be nearly a 400 variation in
    performance between Channel number one and
    Channel number seven.
  • This is due to the distance of the spray
    nozzle from the utilities supply point.
  • The closer channel has the higher washing
    efficiency due to the high pressure of media when
    sprayed out.
  • There is a consideration to add a utility
    supply point at the other side of each washing
    station to increase the pressure of sprayed media
    at locations five, six, and seven to ensure a
    more uniform performance.

24
Performance Qualification of a vial washer
  • Conclusion
  • The PQ testing of the washer is essential to
    ensure the elimination of contamination from the
    vials itself.
  • The quantitative decontamination study can
    provide a high degree of assurance to validate
    the performance of the washer with presetting
    parameters.
  • Requalification of the washer is not necessary
    if no change occurs.
  • Of course, in case of any changes on the vials
    or washing parameters, the washing cycles applied
    should undergo PQ testing again.

25
Performance Qualification of a vial washer
  • Conclusion(continue)
  • Periodic initial contamination testing for
    supplied vials is recommended to ensure all vials
    to be washed are still under validated
    conditions.
  • Periodic testing of washed vials especially
    coming off Channel number five to seven is also
    advisable.
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