CIP Cycle Development: Manual to Automated Cleaning. Torben M. Andersen, McFlusion Inc

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1 CIP Cycle Development: Manual to Automated Cleaning Torben M. Andersen, McFlusion Inc 1

2 CIP Cycle Development: Manual to Automated Cleaning Integrating CIP Design, Recipe & Cleaning Validation For FDA Compliance and Optimized Cleaning. 2

3 Agenda Transition From manual to automated cleaning Feasibility Studies On-site CIP recipe development Examples Equipment, report Equipment Practical examples FDA Trends Our experience Conclusion Do it right and avoid costly mistakes 3

4 Agenda Transition From manual to automated cleaning Feasibility Studies On-site CIP recipe development Examples Equipment, report Equipment Practical examples FDA Trends Our experience Conclusion Do it right and avoid costly mistakes 4

5 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 approach are incorporated in conceptual and/or preliminary engineering design phases. Transition to Automated Cleaning 5

6 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 How can we fulfill existing and/or upcoming validation acceptance criteria? How can we address cross-contamination issues? Why can t we meet acceptance criteria for swabs (µg/cm 2 ) with our existing CIP system? 6

7 Agenda Transition From manual to automated cleaning Feasibility Studies On-site CIP recipe development Examples Equipment, report Equipment Practical examples FDA Trends Our experience Conclusion Do it right and avoid costly mistakes 7

8 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 CIP Flow: 3 70 gallon/minute (10-265 liter/minute).

9 CIP Units for Testing Feasibility Studies CIP Flow: 3 70 gallon/minute ( liter/minute). Pressure/Temperature: psi (1-70 bar)/30-95ºc 2 Detergents: ms/cm or kg Time: Intermittent and continuous Type: Single pass / re-circulation Drying: Hot compressed or forced air 9

10 Spraying Units for Testing Jet Head Spray Devices: Toftejorg and GamaJet. Rotating Spray Devices: Rokon, SaniMidget and Lechler. Static Spray Balls: 180º, 270º, double set. Accessories: wands, spears, adapters, fittings. Prepared for a variety of pressure and flows. Feasibility Studies 10

11 Analytical Instruments Examples Test for: Conductivity, ph, and TOC. Test Types: Client s preferred test types. Development of SOPs for swabs, rinse water sampling. 11

12 On-site Testing & CIP Recipe Development Process Analyze problems. Define goals. Define test method and acceptance criteria. Describe possible cleaning approaches. Feasibility Studies 12

13 On-site Testing & CIP Recipe Development Feasibility Studies Coverages of surfaces to be cleaned Cleaning time Temperature CIP Flow Chemical type and concentration Pressure and impact 13

14 On-site Testing & CIP Recipe Development 1) Cleaning Feasibility Study. 2) Cleaning Feasibility Study Protocol. 3) Test Activities. Feasibility Studies Valid Documentation following GTP & GDP 4) Cleaning Feasibility Report. 14

15 Off-site Tests Using Placebo Equipment 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. 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. Feasibility Studies 15

16 Agenda Transition From manual to automated cleaning Feasibility Studies On-site CIP recipe development Examples Equipment, report Equipment Practical examples FDA Trends Our experience Conclusion Do it right and avoid costly mistakes 16

17 CIP of Poly Vinyl Alcohols Mixer Examples After Before Only city/usp water used, no detergents. 17

18 CIP of Coating Pan After Examples Before Caustic wash, USP rinse, 10 min. cycle time. 18

19 CIP of Coating Pan After Examples Before Before Caustic wash, USP rinse, 10 min. cycle time. 19

20 CIP of Fluid Beds Examples Automated CIP cut cleaning time 75%. 20

21 CIP of Fluid Beds Examples City water consumption cut 60% USP water consumption cut 80% 21

22 Other Types of Equipment Examples We have performed tests on: 750 liter bioreactors 70 liter bioreactors Aseptic filling machines Synthesis reactors and condensers Centrifuges 22

23 Agenda Transition From manual to automated cleaning Feasibility Studies On-site CIP recipe development Examples Equipment, report Equipment Practical examples FDA Trends Our experience Conclusion Do it right and avoid costly mistakes 23

24 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

25 Standard Modular Range of CIP Equipment Equipment 3 main levels for Performance Instrumentation Automation Documentation Qualification. Cost range: from around $25,000 into six figures. 25

26 Agenda Transition From manual to automated cleaning Feasibility Studies On-site CIP recipe development Examples Equipment, report Equipment Practical examples FDA Trends Our experience Conclusion Do it right and avoid costly mistakes 26

27 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 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. FDA Trends 27

28 FDA Trends Actions Addressing Cleaning-Related Issues: 1) Improve SOP s, 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. 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 justification of current methods. 28

29 Agenda Transition From manual to automated cleaning Feasibility Studies On-site CIP recipe development Examples Equipment, report Equipment Practical examples FDA Trends Our experience Conclusion Do it right and avoid costly mistakes 29

30 Conclusion 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. 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. 30

Application of Visible-Residue Limit for Cleaning Validation Richard J. Forsyth and Vincent Van Nostrand By Richard J. Forsyth,Vincent Van Nostrand

October 2, 2005 Application of Visible-Residue Limit for Cleaning Validation Richard J. Forsyth and Vincent Van Nostrand By Richard J. Forsyth,Vincent Van Nostrand Pharmaceutical plants must have visually