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Tài liệu Hvac gpg practical guidance for gmp facilities

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HVAC – GPG Practical Guidance for GMP Facilities By: Norman Goldschmidt VP Genesis Engineers 1 Obj ti Objectives • P Provide id an overview i off th the new HVAC GPG • S Sett expectations t ti on what h t is i and d iisn’t ’t iin th the GPG • Review some key concepts from the guide • Provide selected examples from the guide. • Discuss what’s in the 3 day HVAC class • Bust some Myths 2 Q Question ti #1 • Who are you? • Quality Control / Quality Assurance • Manufacturing Operations • Maintenance / Facilities /Utility Operations • Commissioning / Qualification/ Validation • Engineering • Project Management 3 Q Question ti #2 • Why are you here? • • • • • Learn what’s unique to HVAC for GMP’s Better understand what engineers are doing Explore new resource for compliance Looking for sustainability ideas Boss ordered me to come 4 Q Question ti #3 • What do you know about HVAC? • • • • H, V… What? A little exposure, but not much Familiar, but not expert Experienced in HVAC, but not for pharma • My name is Willis Carrier, I invented HVAC 5 5 Overview O i off the th HVAC GPG What’s In and d What’s Out 6 HVAC – Practical Guidance for GMP F iliti Facilities • What’s in the guide? • • • • • • • • Table of Contents I t d ti and Introduction d Key K Concepts C t Design process for HVAC Design Considerations (w/ Airflow Diagrams) Design Review Equipment q p Spec, p , Install,, Qualify y and Operate p Documentation Requirements Appendices 7 Wh t’ in What’s i the th guide? id ? • Appendices A di • • • • • • • Fundamentals of HVAC HVAC Applications pp and Equipment q p Psychometrics Science Based Risk Management Science and Risk Based Verification Economics and Sustainability Medical Devices • Misc. 8 Wh t’ in What’s i the th guide? id ? • Th The guide id outlines tli structured, t t d rigorous i approach h to HVAC at all stages of it’s life • Key to this approach is Understanding the Product and Process • As is stressed in QBD, ICH Q9 and guides for qualification the HVAC GPG highlights that process qualification, knowledge is paramount in cGMP. • Rules of thumb – are given for conceptual use • M May nott produce d an effective ff ti design. d i • Will not produce an efficient design • Are a way of going wrong with confidence 9 Wh t’ NOT in What’s i the th guide id • • • • • • • Equipment Sizing Load Calculations Recommended Manufacturers Detailed Procedures and MOT Environmental Monitoring Offices and Vivariums Your Product Considerations 10 What’s in the guide S Summary off the new G GPG G • Wh t it is: What i • A guide for pharmaceutical applications of HVAC technology • A quick reference for HVAC nomenclature • A guide for understanding HVAC in relation to Process Development • A collection of practical tips on Pharma HVAC issues • Wh t it is What i not: t • A detailed reference on HVAC science • A cookbook • What it intends to do: • The new GPG is intended to establish a common platform for pharmaceutical professionals of all disciplines to discuss HVAC 11 Key Concepts 12 GMP IIs N Nott At The Th T Top Of A Hierarchy Hi h GMP Not every decision is GMP driven GEP We don't engineer g for the sake of engineering! GBP We are in the pharmaceutical BUSINESS. We can't deliver products at a loss…. Well not for long. Well, long 13 GMP Interacts With Business And Engineering GOOD BUSINESS PRACTICE Marketing Product Development Distribution R&D Community Relations Shareholders GOOD ENGINEERING PRACTICE GOOD MANUFACTURING PRACTICE Product Patient (SISPQ) 14 Facility Equipment Life Cycle Cost Wh t Is What I A Classified Cl ifi d Space? S ? • • • • • • T, RH, T RH airborne ib particles ti l controlled t ll d b below l specified ifi d lilimits it Bioburden (surface and airborne) under control Particles and CFU as shown on Table 5-1 of ISPE Sterile Guide Applies to parenterals, some inhaled products and ointments, and most exposed biopharm API REQUIRES PROCEDURES (people control) Regulatory Authorities define their own • • • • Syste s for Systems o classifying c ass y g ccleanrooms ea oo s FS209 ISO EU 15 ISPE S Bridge between Space S C Classifications f Air Classification FDA CDER Asepetic Guideline 2004 EUROPEAN Annex 1 In Operation Grade 5 Particle level per Action Level CFU/cu.m. cubic meter 0.5 g (plate)) (p micron and larger 3520 1 (ISO 5) (1) In Operation At Rest A 3520 (ISO 5) 3520 (ISO 5) B 352,000 (ISO 7) 3520 (ISO 5) C 3,520,000 (ISO 8) 352,000 (ISO 7) "D" None 3,520,000 (ISO 8) Description CRITICAL AREA Grade 6 35,200 (ISO 6) 7 (3) Supporting clean Grade 7 352,000 (ISO 7) 10 (5) CONTROLLED AREA Grade 8 3,520,000 (ISO 8) 100 (50) CNC (with local monitoring) CNC Unclassified NA NA NA NA Support 100 PCF =100 particles/cu.ft. = 3520 particles/cu.m. 16 CNC = Controlled, Not Classified Lifted from draft ISPE Sterile Baseline Guide How Much Air Flow is Enough for a Cl Classified ifi d S Space? ? • Enough g to meet Regulation g • >20 air changes per hour (USA) • 15-20 minute recovery (Europe) • 10-20 10 20 cfm fresh air/ person (usually no issue) • Enough to meet cooling load • Sensible btu = 1.085 x Q in cfm x ∆T in °F • Enough to offset exhaust + exfiltration • Enough clean air to offset particle generation • Dilution • Displacement 17 Wh t' an Air What's Ai Change? Ch ? • Air Ai change h = th the replacement l t off one room volume l • ACH (air changes per hour) = cubic feet supply air/hr (CFH or CuM/hr) divided by room volume (in cu.ft. or CuM) • Supply air CFH = CFM x 60 Question: • Do I subtract the volume of fixed items in the room? 18 Why Air Changes? Formula for Dilution of Contaminants Where the ventilation rate has been adjusted by a mixing factor K. C = concentration of a gas G = contaminant gas generation rate V = room volume Q = Ventilation rate into or out of the room Q' = adjusted ventilation rate of the volume 19 The Fallacy y of Air Changes g  Contaminant Generation Process Design  Process  People  Contaminant Ingress  Pressurization / Direction of Airflow  Filtration  Risk Mitigation Isolation  Contaminant Removal  Containment  Local Exhaust Ventilation  Room Performance  System Performance Ventilation Effectiveness 20
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