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Location Engineering of Building and Piping Utilities and Piping

Location Engineering of Building and Piping Utilities and Piping. cGMP Facility. General Considerations before Purchase, Construct or Renovate existing facility. Adequate space for future expansion.

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Location Engineering of Building and Piping Utilities and Piping

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  1. Location Engineering of Building and Piping Utilities and Piping cGMP Facility

  2. General Considerations before Purchase, Construct or Renovate existing facility • Adequate space for future expansion. • Zoning laws to allow anticipated development while restricting undesirable Development in the vicinity. • Availability of water (quality and quantity), power, fuel and sewage system. • Ease of accessibility for Employee, customers, suppliers, visitors. • Environmental issues: site history, soil, water, AIR QUALITY, topological issues (potential Earth quakes, flooding, etc..)

  3. Continue…. • Proximity of undesirable activities likely to pollute or act source of insects, odor or microorganisms (based on the hygienic and industrial activities in area) • Availability of a suitable labor force (skilled worker, labor relations and attitudes) • Availability of research institutes and activities to cove part of production chain. • Ability to provide adequate security arrangements. • Political situation-government stability, trade policies, taxation, financial incentives.

  4. Site Preparation and Plant Design • Site arrangement and over-all layout design (green space parking, traffic, Recreation area, tanks, site utilities, etc..) • Water supply and waste management area (waste contractors) • Site security and access (fences, guard, cameras, etc..) • Utilities design, layout, backup (critical utilities backup) • Equipment-design, LAYOUT, spares, capacity.

  5. Continue…. • Safety (Personnel and Equipment), emergency services access. • External architecture should take in account the local environment (temperature, humidity, wind, etc..) • Ease of maintenance (services ducts, cat floor, etc..) • Project management (Managers, consultants, etc..) • Validation Plans and an effective change control procedures. Provision of design and (as built) drawings. • CONTRACTOR (Experience contractor)

  6. Stores Administration Building Production Area Waste Treatment Complex Area Utilities

  7. Stores Administration Building Waste Treatment Complex Area Production Area II (Future Plan) Production Area I Utilities

  8. Design from the beginning tanking the extension plan in account will gives your factory the following advantages! • Less Engineering work and ease for new facility building • Less Cost if it the facility was designed from the beginning to have extra-capacity for the stores, utility and waste management system • System Uniformity for utilities (Equipment in Piping) • Higher assess value factory

  9. Engineering and Design Lifecycle Pre-conceptualDesign Conceptual Design Basic Design Detail Design

  10. Pre-conceptual Design • Layout Options (Single floor vs. Multi floor, Different options of facility design) • Room Classification (Area and Classes) • Commissioning and Qualification Approach • Equipment List • Time Schedule • Price Estimation

  11. Conceptual Design • Layout • Room Classification • Material, product & Personnel flows • Process Automation system • Draft Equipment requirement specifications • Draft qualification Master Plan • Process/clean utilities/ flow diagrams • HVAC zoning • Detailed time schedule • Detailed price estimate

  12. Basic Design • Final Layout with complete building specification • Room Classification (Final) • Material, product & Personnel flows (Final) • Process Automation system (Final) • Equipment requirement specifications • Draft qualification Master Plan • Process/clean utilities/ flow diagrams • Complete HVAC Design • Qualification Master Plan • Estimate price of the project (± 30 %)

  13. Detail Design • Usually done by consultant engineering company • Complete 3D design of the facility including: Engineering, pipe work, HVAC ducting, Electrical Module and wiring • Complete specifications of all part of the project for • Building complete specifications • Equipment (size, capacity, utility requirements, net-working, etc..) • Final walk through model (material flow, personnel flow, etc..) • Possibly with complete operation model (Chem-CAD model)

  14. Integrated Concept for Engineering and Qualification Concept Eng. Basic Eng. Detail Eng. Installation Operation Customer requirements specification Planning and Design VMP+ Primary Risk Analysis Establishment of all Equipment plan, Design Qualification Specifications, tender, offer and order Secondary Risk Analysis - Plant testing - Controlled delivery of the Equipment - Equipment Installation (Positioning) - Utility Piping - Equipment check, primary testing - Installation of piping interconnections Installation Qualification - Testing of installation isometrics - Loop check - Calibration - Installation test - Pressure test - Mechanical final assembly (Equipment fixing) Starting IQ/OQ testing Functional testing with SOP IQ/OQ/PQ

  15. Utilities and Piping in Biopharmaceutical Facilities

  16. Utilities A - Basic Utilities for the production site • Electricity (regular depends on the site of facility) • Continuous supply, possibly with backup generator and UPS for lag-time between electricity cut-off and generator operation • Natural Gas supply (preferable source of clean energy) and/or Diesel tanks • Water supply (Tab water quality) (in case of using water tanks, refer to water reservoir guidelines)

  17. 1 - Steam 2 - Air B - Piping network (Inside and outside the production area) (Steam IN, Steam OUT (condensate)) IN / (OUT opt.) (Clean/Dry steam) 1) Sterilization (equipment, transfer line) 2) Temperature control (Dust free, dry air) IN 1) Culture aeration 2) Valve operation (Pneumatic valves) 3) Culture transfer 4) Standard for out-gas analyzer

  18. 3 - Water - Tap water (for non-production related activities and cleaning) IN - Soft water (for operation of steam generator) IN - Distilled water (Media preparation/ cleaning) IN - Deionized water (Analysis and buffer preparation) IN - Water For Injection (Buffer preparation and purification) IN (WFI) - Chilled water (For temperature control and cooling purpose) IN

  19. 4 - Non-utility piping (Directly in contact with product, byproduct or production vessel) • Media (liquid medium including: medium supplements, Fed-batch medium Acid/Base for pH adjustment) • Buffer • Water (of different quality, based on process stage) • Piping for CIP system • Steam for SIP system (for direct steam injection) • Sterile air for medium aeration and for broth and liquid transfer

  20. Piping Networking Design Point requirement (Flow, temperature, presssure) Valves (Type, specification, location) Insulation requirements. Piping (Material, Diameter (pressure drop)) Connections (Pressure gauge, Filters Deadlegs - Slope - Drainability Steam traps Flexible design for future extension Maintenance - Minimize the pipe length

  21. Piping, Filters and Valves Outside the production site Piping Inside the production area Not in contact with the product In direct contact with the product Piping network Design and Material requirements

  22. Piping Network Why Stainless Steel for Fixed piping system? # Corrosion resistant # Durable, long life # Low expansion coefficient # Easy for clean finishing

  23. Stainless Steel is not Standard word Stainless steel are more than 70 types and many special alloys. The International Codes: 1 - AISI (American Iron and Steel Institute) 2 - ACI (Alloy Casting Institute) All stainless steel are iron bases, with 12%-30% chromium, 0%-22% nickel, and minor amounts of carbon, columbium, copper, molybdenum, selenium, Tantalum and titanium.

  24. Material characteristic (St.St. Pipes) • Wall thickness • Surface finish / treatment • Cleanliness • Material Test Report • Chemical Analysis • Fitting Tolerance • Surface Anomalies (Pits, porosity, scratches, tool marks)

  25. Stainless Steel Types for Biotechnology factories 304 and 316 stainless steels and their L grades (non-magnetic), and not hadenable by heat treatment. Austenitic stainless steel with higher Mo content Duplex stainless steel group Superaustenties in particular (6Mo) Alloy C family (Ni, Cr, Mo family) Cobalt based alloy with high corrosion and wear-resistance Titanium alloys, referred as chemically pure (CP)

  26. Chemical Comparison between different St.St. types

  27. Standards ASME Bioprocessing Equipment (BPE-1997/BPEa-2000) This American National Standard is covering: material, design, fabrication, examination, inspection, testing, certification (for pressure system) and pressure relief (for pressure system) of vessels and piping for bioprocessing system, including sterility and cleanability (Part SD), dimensions and tolerance (Part DT), surface finish requirement (Part SF), material joining (Part MJ), and seals (Part SG) This standard is applied to: • All parts that contact with product, raw material, and/or product intermediates during manufacturing, process developing or scaling up. • All equipments or systems that are critical part of product manufacture, such as Water for Injection (WFI), clean steam, ultrafiltration, intermediate product storage and centrifuges.

  28. ASME Design guidelines (BPE – Part SD - 3) SD - 3.1.Cleanability SD - 3.2.Sterility SD -3.3.Surface finish SD - 3.4.Material of construction SD-3.5. Fabrication SD-3.6. Static-O-ring, seals and gaskets SD-3.7. Connections and Fittings SD-3.8. Exterior Design SD-3.9. Containment SD-3.10. Miscellaneous design details SD-3.11. System design SD-3.12. Drainability

  29. ASME Design guidelines (BPE – Part SD - 4) • SD-4.1 Instrumentation • SD-4.2 Fittings and hoses • SD-4.3 Centrifuges • SD-4.4 Filtration equipment • SD-4.5 Pumps • SD-4.6 Pressure (hygienic) valve • SD-4.7 Vessel design • SD-4.8 Agitators and mixers • SD-4.9 Heat exchanger equipment • SD-4.10 Cell disrupters • SD-4.11 High purity water and steam systems • SD-4.13 Generators and clean/ pure steam generators • SD-4.14 Sterilizers/ autoclaves • SD-4.15 CIP systems and design

  30. Welding Technique – orbital welding - Automatic (preferable) - Argon (pure gas) Practice – welder quality - certificate Test – x-ray

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