Incorporating The ASME BPE Guidelines For CIP For Biopharma Equipments
•
19 j'aime•12,712 vues
CIP guidelines for Processing Skids and Transfer Lines for Bio Pharmaceutical Industry.
Recommandé
Recommandé
Contenu connexe
Tendances
Tendances (20)
Similaire à Incorporating The ASME BPE Guidelines For CIP For Biopharma Equipments
Similaire à Incorporating The ASME BPE Guidelines For CIP For Biopharma Equipments (20)
Incorporating The ASME BPE Guidelines For CIP For Biopharma Equipments
- 1. Incorporating the ASME - BPE guidelines for designing the Cleaning In Place of Bio Pharma Equipment Vishal Wagh Director Marketing adam fabriwerk pvt ltd Mumbai, India www.adamfabriwerk.com 1
- 2. Summary The CIP System CIP of Vessel Spray Devices Tank Nozzle design for CIP Vessel Design Features Process Line Design for CIP Drainability Dead Legs Complexity of Design for CIP Machined Block Valves www.adamfabriwerk.com 2
- 3. The CIP System www.adamfabriwerk.com 3
- 4. CIP of Vessel www.adamfabriwerk.com 4
- 5. Spray Devices Fixed devices provide 5-7 feet of coverage from the device Flow typically ≥2.5 GPM / foot (31 lpm / meter) tank circumference Example: tank diameter = 3 feet, Spray ball flow = π x 3 ft x 2.5 gpm/ ft ≥24 GPM Spray device design criteria Provide adequate flow for operation Must be self-draining MOC compatible with cleaning agents SS with finish equal to the tank Commonly solution directed to upper 25-30% of tank Coverage of lower surfaces by sheeting Must provide 100% coverage of tank internals www.adamfabriwerk.com 5
- 6. Tank Nozzle Design for CIP Minimize L/D (2:1 target ratio) to ensure coverage from spray balls Recommended minimum nozzle size: 1”ASME, BPE 2007 Prefer nozzles flush with interior of vessel www.adamfabriwerk.com 6
- 7. Tank Nozzle Design for CIP L/A (Length / Annular width) ≤2 for nozzles with dip tubes, splash tubes, or other inserted lines. NOT ACCEPTABLE . ACCEPTABLE www.adamfabriwerk.com 7
- 8. Tank Nozzle Design for CIP Vessel Sidewall Fittings Avoid nozzles that extend from the vessel wall below spray devices (e.g. hygienic ferrules). These may not be cleanable. Recommended minimum slope is 5°ASME-BPE 2007 . . . INSTRUMENT HYGIENIC BOLTED HYGIENIC PORT FERRULE FITTING . . Ingold Port – Difficult to . susceptible to clean below NA Connect leakage around level of spray O ring ball www.adamfabriwerk.com 8
- 9. Tank Nozzle Design for CIP Vessel Sidewall Fittings NA Connect on vessel side wall with accessories like Sampling valve, Temperature sensor, DPT can be fitted www.adamfabriwerk.com 9
- 10. Vessel Design Features Smooth surface – rounded corners Aids soil removal, does not harbor microorganisms Typically 15-20 micro inch roughness after EP Appurtenances selected and installed for drainability Must drain freely bottom agitator pads drain valves Minimize number of shell nozzles L/D ≤2 Dished man way covers with minimum projection. www.adamfabriwerk.com 10
- 11. Process Line Design for CIP Flow rate requirement to flood process lines to ensure Cleaning In Place Use of Sanitary Flow meters in CIP supply line to ensure desired flow rates www.adamfabriwerk.com 11
- 12. Drainability - Slope Maintain slope after installation Supports essential to maintain slope Ensure lines will not slip through supports Maintain slope during CIP and SIP Thermal expansion can change slope Challenging for flexible hose assemblies: Coefficient of thermal expansion for polymers is often >10x stainless steel May sag when heated Often requires aggressive slope to ensure no low Points www.adamfabriwerk.com 12
- 13. Drainability - Connections Welds preferred Hygienic union fittings Often required for access, maintenance, assembly Gaskets extrude Limit by tightening clamps to specified torque Challenges : Misaligned fittings Materials that cold flow, extrude or swell Seals are to meet one of the following extrusion categories Category 1: 0.025 in. (0.6mm) Category 2: 0.008 in. (0.2 mm) Minimal liquid hold up still occurs www.adamfabriwerk.com 13
- 14. Dead legs Dead Leg: “An area of entrapment in a vessel or piping run that could lead to contamination of the product Any branch of a line through which liquid does not flow during CIP or steam during SIP Includes Tees Closed valve branches Vessel nozzles Target ratio: L/D ≤2 (extension from flow path / inner diameter) (BPE 2009, SD3.11.1) Not always practically achievable If not, confirm successful CIP and SIP during validation L /D > 2 often validatable for SIP depending on Turbulent steam flow Dimensions: Length and Diameter Orientation www.adamfabriwerk.com 14
- 15. Complexity of Design for CIP Simple case of orienting a branch for CIP and SIP Downward branches trap condensate and residue Upward orientation is best for sterilization Steam less dense than air Rapid draining of condensate But during CIP, air is not easily cleared from an upward tee Cleaning is more difficult than SIP Depending on orientation and diameter even L/D = 2 may be difficult to clean Solutions Minimize length of dead leg Horizontal orientation where possible High flow and minimal length enable flushing air from tee Use full-diameter tees (1.5”branch for 1.5”run) www.adamfabriwerk.com 15
- 16. Machined Block Valves Advantages of Block Valves Compact Design – Low Space requirements Low hold up volume, small welled area Greatly REDUCED DEAD LEGS No internal weds, shorter cleaning times All blocks designed for OPTIMISED DRAINING Made to Customer Specifications Reduced Total Cost of Ownership www.adamfabriwerk.com 16
- 17. Machined Block Valves www.adamfabriwerk.com 17
- 18. Questions ? www.adamfabriwerk.com 18