cip cycle development interphex 060120 - ??cip cycle development: manual to automated cleaning...

Download CIP Cycle Development INTERPHEX 060120 - ??CIP Cycle Development: Manual to Automated Cleaning Integrating CIP Design, Recipe Cleaning Validation For FDA Compliance and Optimized 2

Post on 22-May-2018

213 views

Category:

Documents

0 download

Embed Size (px)

TRANSCRIPT

  • CIP Cycle Development:Manual to Automated CleaningTorben M. Andersen, McFlusion Inc

    1

    McFlusion Inc

  • CIP Cycle Development:Manual to Automated Cleaning

    Integrating CIP Design, Recipe &

    Cleaning Validation

    For FDA Compliance and Optimized

    2

    For FDA Compliance and Optimized

    Cleaning.

  • Agenda

    Transition From manual to automated cleaning

    Feasibility Studies On-site CIP recipe development

    Examples Equipment, report

    3

    Equipment Practical examples

    FDA Trends Our experience

    Conclusion Do it right and avoid costly mistakes

  • Agenda

    Transition From manual to automated cleaning

    Feasibility Studies On-site CIP recipe development

    Examples Equipment, report

    4

    Equipment Practical examples

    FDA Trends Our experience

    Conclusion Do it right and avoid costly mistakes

  • Making the Transition to Automated Cleaning:

    These new challenges require groundwork studies and tests of cleaning procedures (manual or automated CIP).

    1) Engineering and cleaning validation are synchronized.

    2) A successful and validatable cleaning method and

    Transition to Automated Cleaning

    5

    2) A successful and validatable cleaning method and approach are incorporated in conceptual and/or preliminary engineering design phases.

  • Typical Questions to be Addressed:

    How fast can we clean?

    What is the lowest possible USP water consumption?

    Can we clean without detergents?

    Can we make cost/benefit justifications for automated CIP?

    Can we guarantee the cleaning method?

    Transition to Automated Cleaning

    6

    Can we guarantee the cleaning method?

    How can we fulfill existing and/or upcoming validation acceptance criteria?

    How can we address cross-contamination issues?

    Why cant we meet acceptance criteria for swabs (g/cm2) with our existing CIP system?

  • Agenda

    Transition From manual to automated cleaning

    Feasibility Studies On-site CIP recipe development

    Examples Equipment, report

    7

    Equipment Practical examples

    FDA Trends Our experience

    Conclusion Do it right and avoid costly mistakes

  • On-site Testing & CIP Recipe Development

    Commissioning & decommissioning in hours.

    On-site cleaning tests typically performed in 1 to 5 days.

    Feasibility Studies

    8

  • CIP Units for Testing

    Feasibility Studies

    9

    CIP Flow: 3 70 gallon/minute (10 - 265 liter/minute).Pressure/Temperature: 10-1000 psi (1-70 bar)/30 - 95C2 Detergents: 0 - 200 mS/cm or 0 - 10.00 kgTime: Intermittent and continuousType: Single pass / re-circulationDrying: Hot compressed or forced air

  • Spraying Units for Testing

    Feasibility Studies

    Jet Head Spray Devices: Toftejorg and GamaJet.

    Rotating Spray Devices:Rokon, SaniMidget and Lechler.

    Static Spray Balls: 180, 270, double set.

    Accessories: wands, spears,

    10

    Accessories: wands, spears, adapters, fittings.

    Prepared for a variety of pressure and flows.

  • Analytical Instruments

    Examples

    11

    Test for: Conductivity, pH, and TOC.Test Types: Clients preferred test types.Development of SOPs for swabs, rinse water sampling.

  • On-site Testing & CIP Recipe Development

    Process

    Analyze problems.

    Define goals.

    Define test method and acceptance

    Feasibility Studies

    12

    Define test method and acceptance criteria.

    Describe possible cleaning approaches.

  • On-site Testing & CIP Recipe Development

    Feasibility Studies

    Cleaning time

    Coverages of surfaces

    to be cleaned

    13

    Pressure and impactChemical type and

    concentration

    Temperature CIP Flow

  • On-site Testing & CIP Recipe Development

    Feasibility Studies

    1) Cleaning Feasibility Study.

    2) Cleaning Feasibility Study Protocol.

    14

    3) Test Activities.

    4) Cleaning Feasibility Report.

    Valid Documentation following GTP & GDP

  • Off-site Tests Using Placebo Equipment

    Feasibility Studies

    Simulation of cleaning on placebo production equipment with or without active product.

    Detergent simulations in laboratory settings on active ingredients to test product removal capabilities (e.g. PACE studies from Steris).

    Off-site tests minimize cost, production down time.

    15

    Off-site tests minimize cost, production down time.

    Off-site tests cannot substitute on-site cleaning tests in actual production environment and/or equipment, which is expected to be applied for the final processes.

  • Agenda

    Transition From manual to automated cleaning

    Feasibility Studies On-site CIP recipe development

    Examples Equipment, report

    16

    Equipment Practical examples

    FDA Trends Our experience

    Conclusion Do it right and avoid costly mistakes

  • CIP of Poly Vinyl Alcohols Mixer

    Examples

    Before

    After

    17

    Only city/USP water used, no detergents.

    Before

  • CIP of Coating Pan

    Examples

    After

    18

    Caustic wash, USP rinse, 10 min. cycle time.

    Before

  • CIP of Coating Pan

    Examples

    AfterAfter

    19

    Caustic wash, USP rinse, 10 min. cycle time.

    BeforeBefore

  • CIP of Fluid Beds

    Examples

    20

    Automated CIP cut cleaning time 75%.

  • Examples

    CIP of Fluid Beds

    City water

    consumption

    cut 60%

    21

    USP water

    consumption

    cut 80%

  • Examples

    Other Types of Equipment

    We have performed tests on:

    750 liter bioreactors

    70 liter bioreactors

    Aseptic filling machines

    22

    Aseptic filling machines

    Synthesis reactors and condensers

    Centrifuges

  • Agenda

    Transition From manual to automated cleaning

    Feasibility Studies On-site CIP recipe development

    Examples Equipment, report

    23

    Equipment Practical examples

    FDA Trends Our experience

    Conclusion Do it right and avoid costly mistakes

  • Standard Modular Range of CIP Equipment

    Equipment

    Unit program designed for full transition to automatic cleaning with focus on practical

    implementation and acceptable cost/benefit.

    24

  • Standard Modular Range of CIP Equipment

    Equipment

    3 main levels for

    Performance

    Instrumentation

    Automation

    Documentation

    25

    Documentation

    Qualification.

    Cost range: from around $25,000 into six figures.

  • Agenda

    Transition From manual to automated cleaning

    Feasibility Studies On-site CIP recipe development

    Examples Equipment, report

    26

    Equipment Practical examples

    FDA Trends Our experience

    Conclusion Do it right and avoid costly mistakes

  • Increased FDA Focus on Cleaning-Related Issues:

    1) Inadequate, inconsistent manual cleaning.

    2) Inadequate scientifically-based cleaning cycle development rationale.

    Analytical methods

    Recovery studies

    Worst-to-Clean definitions in current cleaning

    FDA Trends

    27

    Worst-to-Clean definitions in current cleaning validation processes

    3) Cleaning related issues in existing, validated (CIP) processes.

    4) Lack of consistency in CIP recipe cleaning methods on identical products within the same company.

  • Actions Addressing Cleaning-Related Issues:

    1) Improve SOPs, training and acceptance criteria for cleaning release or consider CIP cleaning for consistent adequate cleaning.

    2) Develop validated analytical methods.Perform recovery studies, group equipment, define hot spots and hard-to-clean areas, and define and justify worst-to-clean equipment.

    FDA Trends

    28

    clean equipment.

    3) Failure investigation reports with recommended solutions.Groundwork / initial studies to provide guarantees that next validation will succeed and survive.

    4) Investigate to generate documentation and justificationof current methods.

  • Agenda

    Transition From manual to automated cleaning

    Feasibility Studies On-site CIP recipe development

    Examples Equipment, report

    29

    Equipment Practical examples

    FDA Trends Our experience

    Conclusion Do it right and avoid costly mistakes

  • Do It Right, Avoid Costly Mistakes

    Description of CIP recipe(s).

    Definition of possible use, type(s), and amount of detergents.

    Water usage for cleaning.

    Description of flow / pressure conditions.

    Conclusion

    30

    Description of flow / pressure conditions.

    Description of cleaning devices to be applied for cleaning.

    Establishment of acceptance criteria.

    Cost / benefit analyses covering possible solutions.

    Establishment of linked engineering design and validation planning.

Recommended

View more >