compounding pharmacy cleanroom design for usp/fda compliance chris munoz, pharmd
TRANSCRIPT
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Compounding Pharmacy Cleanroom Design for USP/FDA
ComplianceChris Munoz, PharmD
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Why Are We Here Today?
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New England Compounding Center
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Our Goal:Demystify the
Regulations
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The Hard Facts About the DQSA
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2014 FDA/State Meeting
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2014 FDA/State Meeting
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Current Good Manufacturing Practice
(cGMP)
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cGMP Guidance (Draft)
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cGMP Guidance (Draft)
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Today’s Regulatory Environment
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2015 FDA/State Meeting
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2015 FDA/State Meeting
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Section 503A: Traditional
Compounding Pharmacies
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ASHP Guidelines
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503A Final Guidance
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503A Final Guidance
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Quick RecapBefore We Move On to
USP
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State Oversight:USP <797>
(Under Revision)
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USP <797> Draft
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State Oversight:USP <800>
(Draft)
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USP <800> Draft
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USP <800> Draft
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USP <800> Draft
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Compounding Cleanroom Design
Mike Buckwalter Terra Universal, Inc.
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Regulations & agencies that provide guidelines on cleanroom standards & practices:
Regulators: Who says what’s clean?
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Regulation/Agency Industries Served Background
Fed-Std-209E/US General Service Administration
Fed-Std-209 initially regulated aerospace and semiconductor industries, but assumed international scope
Specified the familiar classifications: “Class 10, “ Class 100,” etc. Each classification referred to the number of permissible particles per cu. ft. Officially canceled in 2001, but still widely used
ISO 14644/International Standards Organization
All. Metric measurement adhere to international conventions.
Superseded Fed-Std-209E starting in 2001. Correlates roughly as follows:Fed-Std-209E ISO 14644Class 1 ISO 3Class 10 ISO 4Class 100 ISO 5Class 1000 ISO 6Class 10,000 ISO 7Class 100,000 ISO 8
EU GMP* ClassificationPharmaceutical Manufacturing in both the European Union and US
Uses the designations Class A, B, C and D. Classes “A” and “B” correspond to ISO 5, but “A” specifies a stricter “in operation” air change rate.
British Standard (BS) 5295
Great Britain Uses the designations Class 1, Class 2, Class 3, Class 4; superseded by ISO 14644
ISO I, 2 and 9 have no direct 209E equivalent
*European Union Good Manufacturing Practices
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Allowable airborne particulates, by cubic meter*:*For ISO 1 through 6, this list refers to quantities of 0.3 micron-sized particles allowed in a controlled environment, and for ISO 7 through 9, it refers to 0.5 micron-sized particles. Source: ISO 14644-1
Particles: ISO level limits
ISO Level Particle Count
1 Less than 10
2 10
3 103
4 1,020
5 10,200
6 102,000
7 352,000
8 3,520,000
9 35,200,000
FYI:A cubic meter of typical room air contains ± 52 million 0.3-0.5 micron particles.
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Particle Counter
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• Uni-directional air flow controls contaminants more effectively than uncontrolled, multi-directional air flow• Turbulence stirs-up particles• Fan/filter units force air through filters in a laminar fashion• FFUs also provide uniform air speed with proper control system• Presence of furnishings, equipment and personnel interrupts laminarity; air hits surfaces and bounces• Rapid movements create turbulence
Laminar vs Turbulent Air Flow
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Air movement promotes cleanliness. Filtered air sweeps particles toward the floor and exhaust vents. Air exchange rates shown here are IEST* recommendations but are occasionally revised downward: high ACR velocity can create unwanted turbulence. USP specifies 30 ACPH for ISO7.
Air Changes Per Hour (ACPH)
ISO Level Recommended ACR Ceiling FFU Coverage
1-2 360 – 600/hr 80 – 100%
3 360 – 540/hr 60 – 100%
4 300 – 640/hr 50 – 90%
5 240 – 480/hr 35 – 70%
6 150 – 240/hr 25 – 40%
7 60 – 90/hr 15 – 20%
8 5 – 48/hr 5 – 15%
9 less than 5 – 48/hr Less than 5%
ISO recommendations:
Range dependent upon variables like room design and access frequency.
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FYI:Air change rates in an air-conditioned house average about one(1) per hour.
*Institute of Environmental Sciences and Technology
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Calculate with this formula:
No. of FFUs = (Air Changes per Hour ⁄ 60) × (Cubic feet in room ⁄ 650*)
*Refers to the cubic feet/minute (CFM) of a typical 2 x 4 loaded FFU at medium speed.′ ′
Example of a 10’ x 10’ x 10’ ISO 7 room:60 – 90 ACH is required, therefore, you need 2-3 FFUs.
Calculations: • (60/60) x (1000/650) = 1.54 • (90/60) x (1000/650) = 2.31
Discussion: An ISO 7 room is more forgiving than (for example) ISO 5, however the 10-foot ceiling warrants a rounding up of the calculation fractions.
Air Change Rate: FFU coverage
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• Moving (vs. stagnant) air = a cleaner environment• Too forceful = unnecessary turbulence• Consider room design: choose the higher end of the range to account for a higher ceiling (greater travel distance), for example
Airflow Design Basics
ISO Level Air Speed*
1-2 0.305 – 0.508 (60 – 100)
3 0.305 – 0.457 (60 – 90)
4 0.254 – 0.457 (50 – 90)
5 0.203 – 0.406 (40 – 80)
6 0.127 – 0.203 (25 – 40)
7 0.051 – 0.076 (10 – 15)
8 0.005 – 0.041 (1 – 8)
9 < 0.005 – 0.041 (1 – 8)
*Expressed as meters/second (m/s). Within parentheses are feet/minute (f/m). (Source: IEST)
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Factors that can influence air speed (velocity), air changes rates, fan/filter coverage, turbulence and air balancing:
• Personnel: quantity, speed and movement patterns• Equipment: quantity, energy consumption and exhaust• Vents and Plenums: location, quantity• Ceiling height• Entryways: types, quantity• Ducting: type, size, direction• Floor plan/number of rooms• Air handling systems/HVAC
Room Variables
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• Forces air out of a room• Referred to as an “isolation” enclosure• Control systems and/or adjustable air vents control positive pressure• Protects samples, not external environment (leaks are relatively unimportant)• Softwall cleanrooms won’t maintain pressure• Air can be recirculated to extend filter life• Pressure requirement: typically 0.025 - 0.05” water column (WC) differential between rated and unrated space or between rooms of differing ISO ratings• Measure & log room pressure and differentials
Pressure: Positive (USP-797)
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®Dwyer Instruments, Inc.
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Pressure: Negative (USP-800)
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• Exhaust system removes more air than enters room (min. 0.01” WC negative pressure)• Referred to as a “containment” enclosure• Exhaust air fed to dedicated in-house removal system; may require “scrubbing” to remove biohazards• Leaks allow particle ingress; walls must be sealed• Protects people outside the room from bio-hazards• Air enters through HEPA floor louvers or ceiling HEPA filters; recirculation generally not permitted• Requires appropriate ducting system tied to in-house exhaust system• 0.025” - 0.05” water column (WC) pressure difference between rooms of differing ISO ratings
Laminar-flow cleanroom
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Sterile-to-Sterile HD Compounding
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Sterile-to-Sterile HD Compounding
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Non-Sterile-to-Sterile HD Compounding
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Non-Sterile-to-Sterile HD Compounding
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Temperature & Humidity
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Temperature: usually 5 - 10°F below ambient level to offset heat-generating equipment and provide comfort for garbed technicians
Relative Humidity (RH): Usually 40 - 60%, but is dependent upon application/industry. Low RH invites static electricity (ESD); high RH provides environment for micro-organisms to flourish
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Automated Control Systems
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Summary: Cost Considerations
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Modular Cleanrooms: Reduce cost and installation schedule compared to brick-and-mortar rooms – USP 797 designs begin around $15,000. FFUs can be added for nominal cost if requirements change.
Exhaust Air (503B and non-sterile-to-sterile compounding): Requires additional expense of air exhaust ducting and ceiling centrifugal exhaust fan, typically installed by a local contractor
Air Conditioning: To keep control costs, use existing facility HVAC system. Supplemental A/C modules add cost and potentially fresh make-up air supply
Certification: Automated control system adds up-front cost (but typically only 10-20% of room cost) but simplifies and speeds up certification, saving in long-term expenses, as well as controlled operation expenses
Energy: Upgrade to ECM fan/filter units to increase energy efficiency and comply with local energy requirements (e.g., California’s Title 24)
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Pre-submitted Questions
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• Enclosed, controlled space; may serve as the ISO 5 primary engineering control (PEC) inside an ISO 7 secondary engineering control (SEC) cleanroom• Filtered, laminar airflow• Material compatibility• Controls: Particle filtration, pressure, sterilization, temperature, static neutralization• USP designs: - Compounding Aseptic Isolator (CAI): protects sample (no containment) - Compounding Aseptic Containment Isolator (CACI): protects sample and operator (for hazardous drug compounding)
Isolators (Glove Boxes)
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• AKA “clean bench” or “laminar-flow cabinet”• Horizontal or vertical laminar flow• Positive pressure• Compatible materials:
- Acrylic: economical; damaged by IPA- Static-dissipative PVC eliminates ESD*- Polypropylene: resists damage from chemicals- Powder-coated steel: strong, damage-resistant- Stainless steel: strong, resists cleaner & solvent damage
• Controls: ionizing bars (neutralizes static), UV sterilization (disinfects), differential pressure gauges, air-speed gauge• Specialty designs: PCR, IV rods, explosion-proof, perforated surfaces
Laminar Flow Hoods
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*Electro-static discharge
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Negative-pressure containment hoods; filtered exhaust removes pathogens (but not vapors). CDC/NSF classifications:Class I: partial containment protects personnel but not the productClass II: protects personnel and the product
Class III: Maximum containment for highest-risk pathogens; small amounts of volatile toxic chemicals or radionuclides. Filtered exhaust and make-up air. This cabinet is a glovebox, not a hood
Biological Safety Cabinets
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Class II Type Characteristics
A1 min. air velocity of 75 fpm; low to moderate risk; 30% exhausted air into lab
A2 min. air velocity of 100 fpm; low to moderate risk; exhaust into lab; some negative pressure
B1 min. air velocity of 100 fpm; hard-ducted, moderate risk with some volatile chemicals or radionuclides; 70% exhausted air out of lab
B2 min. air velocity of 100 fpm; low to moderate risk with some volatile chemicals or radionuclides; 100% exhausted air out of lab
Class II A2 BSC
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• Purpose: exhausts fumes to ducting system• Negative pressure• Baffling system ensures no air escape (“second-pass air”) at the operator interface• Not ISO rated• Ductless designs incorporate carbon filters to allow in-door air release
Fume Hood
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• Interlocked doors prevent cross-contamination• Smooth, chemical-resistant internal surfaces (electropolished SS)• Isolated electronic interlock• Optional Air Shower minimizes particle ingress• Security features include biometric readers, logged access, wireless remote access control
Transfer Options: Pass-Throughs
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Open Q&A Session
• During the webinar, please submit questions to us through the Q&A chat box within your interface
• After the webinar has ended, please direct all questions to [email protected]
• Each participant will receive an email in the coming days containing a link to the video recording of this webinar and a PDF copy of Terra Universal’s white paper on the impact of shifting USP/FDA regulations on pharmacy cleanroom design
• To contact Terra Universal directly, call 714-578-6000
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