Advanced Barrier Concepts | Specialists in vaporized hydrogen peroxide applications

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(Middleton, WI)

Sterile process development for Phase 1 Clinical DNA Product including:
- System validation of a rigid wall isolator
- Sterile transfer system
- Autoclave
- VHP®1000
Environmental monitoring
- Isolator
- Laminar flow hoods
- Manufacturing area
Revalidation performed after equipment modification
Participation in SOP development and reviews

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(Waco, TX)

Facility design, review and optimization
- HVAC air exchanges
- Temperature control
Validation protocol development and execution
- Flexible wall sterility test isolator system
- VHP1000
Hydrogen peroxide gas D-value determination of test carriers

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(Westborough, MA)

Facility design, review and optimization
Sterilant generator manifold
Validation protocol development and execution
- Rigid wall sterility test isolator system
- Autoclave-interface
- VHP1000
Hydrogen peroxide gas D-value determination of test carriers
SOP Generation

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(Toronto, Ontario)

VHP1000 cycle optimization
Successful revalidation in an existing sterility test lab
VHP1000 PQ
Equivalency protocol development and execution
- Relocated sterility test lab

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(Swiftwater, PA)

Factory Acceptance Testing (FAT) protocol development
- Clinical filing facility isolators
IQ/OQ/PQ protocol development
Execution
- VHP1000
- Clinical filling facility isolators
Hydrogen peroxide gas D-value determination of test carriers
Environmental qualification and monitoring plan development
Media fill / sterile challenge protocol development
Execution support

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(Swiftwater, PA)

VHP1000 cycle development
PQ protocol development and execution
- Isolated high speed filling line
UV D-value determination of test carriers
UV pass-through chamber cycle development
Validation execution
Media fill / sterile challenge assistance
Drafted Regulatory Licensing documents (ELA submission)
Annual System revalidation testing

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(Irvine, CA)

Design consultation (sterilant port locations, control issues)
- Rigid wall isolator
Validation planning
- Sterile liquid process
- Powder filling process
VHP1000 cycle development
- First and second filling lines
Isolator validation assistance
- First and second filling lines

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(Columbus, OH)

VMP development
Hydrogen peroxide gas D-value determination of test carriers
IQ/OQ and PQ protocol development and execution
- VHP1000
- Flexible wall sterility testing isolators

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(Boulder, CO)

IQ/OQ, cycle development, and PQ protocol development
- VHPM1000
- Clinical filling isolator
Execution
- Clinical filling isolator
IQ/OQ and PQ protocol development and execution
- VHP1000
- Sterility testing isolator
Hydrogen peroxide gas D-value determination of test carriers

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(Round Lake, IL, and Lessines, Belgium)

VHP1000 manifold design
- Sterile liquid processing isolator
System specification and design review
- Rigid wall sterility test isolator

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(Cambridge, MA)

System specification and design review
- Rigid wall sterility test isolator system
Hydrogen peroxide gas D-value determination of test carriers
IQ/OQ and PQ protocol development and execution
- VHP1000
- Sterility testing isolators
Design review
- Hydrogen peroxide liquid
- Hydrogen peroxide spray/fog
- Hydrogen peroxide gas
- Steam sterilization processes
- Form-Fill-Seal machine used for IV solution filling

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(Rockville, MD)

Facility review, design consultation, and process development
- Sterile batch injectable clinical filling line application inside a rigid wall isolator system using hydrogen peroxide gas decontamination
Cycle development testing
- VHP1000
IQ/OQ/PQ protocol development and execution for multiple rigid wall isolator systems
- Filling
- Autoclave interface
- Transfer
- Two VHP1000s

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(Wilmington, DE)

Set-up and system optimization
- Flexible wall sterility test isolator
VHP1000 training
Validation training

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(Research Triangle Park, NC)

Facility design review and optimization
- HVAC air exchanges
- Exhaust systems
Validation protocol reviews and execution assistance
- Flexible wall sterility test isolators with autoclave interface system

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(New York, NY)

Hydrogen peroxide gas manifold system design review
- BSL3 animal room decontamination
- (US government facility project)

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(Rush City, MN)

Hydrogen peroxide residue testing
- Potential rigid wall isolator materials

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(MSD Clermont-Ferrand, France)

Design consultation and process development
- Sterile batch ophthalmic filling line application inside a rigid wall isolator system using hydrogen peroxide gas decontamination
Factory Acceptance Testing (FAT) cycle development testing
- VHP1001 filling line isolators located in France and Italy
IQ/OQ and PQ protocol development
- Three (3) rigid wall isolators
- One (1) soft wall isolator
- Three (3) VHP1001s
Execution
- Three (3) rigid wall isolators
- One (1) soft wall isolator
- Three (3) VHP1001s
Hydrogen peroxide gas D-value determination of test carriers
Successful revalidation
- Decontamination cycle

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(MSD Clermont-Ferrand, France)

Hydrogen peroxide gas D-value determination of test carriers
IQ/OQ, PQ, and VHP1001 equivalency protocol development for second identical ophthalmic filling line inside an isolator system
Execution
- Second identical ophthalmic filling line inside an isolator system

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(MSD Clermont-Ferrand, France)

Design consultation and process development
- Sterile batch injectable filling line application inside a rigid wall isolator system using hydrogen peroxide gas decontamination
VHP1001 cycle development testing in conjunction with isolator vendor
IQ/OQ and PQ protocol development
- Multiple rigid wall isolator systems
- Flexible wall isolators
Execution
- Multiple rigid wall isolator systems
- Flexible wall isolators
Equivalency studies for Multiple VHP1001s using NIR sensor technology

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(Lancaster, PA)

Facility design review and optimization
- HVAC air exchanges
- Temperature control
Validation protocol development and execution
- Flexible wall sterility test isolator system
Successful revalidation of decontamination cycles
- Second VHP1000
Equivalency testing
- Second VHP1000
Sterility test isolator suite
- New laboratory design review
- Exhaust system design/qualification
- Post-relocation equivalency revalidation studies
Hydrogen peroxide gas D-value determination of test carriers
IQ/OQ and PQ protocol development and execution
- Double-door autoclave and adjoining interface isolator

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(Elkton, VA)

Design consultation and process development
- Sterile bulk powder filling application in rigid wall isolators using hydrogen peroxide decontamination, including sterilant manifold systems in production areas
Sterilizable transfer system development assistance
- Bulk powder transport and delivery in disposable bags
IQ/OQ and Factory Acceptance Testing (FAT) cycle development
- VHP1000
Hydrogen peroxide gas D-value determination of test carriers
PQ protocol development for execution
- 5 isolators
- 5 VHP1000s
- Successful equivalency studies on the multiple generator system

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(West Point, PA)

Barrier technology prototype research, development, and feasibility testing
Peroxide Plus (steam/Hydrogen Peroxide) sterilization methods development and testing
Factory Acceptance Testing (FAT), protocol development and execution
- High speed barrier filling system
- Depyrogenation tunnel
- SIP
- Related systems
IQ/OQ protocol development and execution
- High speed barrier filling system
- Depyrogenation tunnel
- CIP/SIP
- Related systems

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(West Point, PA: BTMC- Biotechnology Manufacturing)

Leak remediation
- Prototype seed lab isolator system
IQ/OQ and PQ protocol development for VHP1000
Execution
- Multiple isolator system

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(Augusta, GA)

Facility design review and optimization
- HVAC air exchanges
- Temperature control
Factory Acceptance Testing (FAT) studies at isolator vendor
Hydrogen peroxide gas D-value determination of test carriers
Validation protocol development and execution
- Rigid wall filling line and sterility test isolator systems using multiple VHP1000s and VHPM1000s

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(Richmond Hill, Ontario)

Hydrogen peroxide gas manifold system development
- Production ophthalmic barrier filling system
Hydrogen peroxide gas manifold system
- Clinical injectable barrier filling system
Protocol development and execution
- VHP1000
Cycle development
- Three (3) rigid wall isolators comprising the injectable barrier filling system with oven and autoclave interface
Hydrogen peroxide gas D-value determination of test carriers
Design review, protocol development, and execution of hydrogen peroxide gas cycle development studies
- High speed injectalbe filling line interface to 2 VHP1000s in parallel

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(Kalamazoo, MI)

Hydrogen peroxide gas process development, validation strategy consultation, and cycle development or high speed barrier filling system

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(Buenos Aires, Argentina)

Facility design review and optimization
Validation protocol development and execution
- Rigid wall sterility isolator system
- Two VHP1001s
Hydrogen peroxide gas D-value determination of test carriers
SOP Generation

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(Collegeville, PA)

Facility design review and optimization
- HVAC
- Outside exhaust system
Isolator design optimization to permit VHP1000 decontamination
- Fan istallation
- Eradication of leaks
- Materials optimization
Validation protocol development and execution
- Rigid wall sterility test isolator system with autoclave interface

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(Crailsheim, Germany)

Design consultation and process development (sterilization specifications)
- Sterile filling application involving isolation and hydrogen peroxide gas decontaminatio
Factory Acceptance Testing (FAT) protocol development

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(Marietta, PA)

Facility design review and optimization
- HVAC air exchanges
- Temperature control
Validation protocol development and execution
- Flexible wall sterility test isolator system
- VHP1000

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(West Chester, PA)

Process development, feasibility testing, and validation
- Surface sterilization of an antibiotic centrifuge/dryer system using hydrogen peroxide gas
IQ/OQ and PQ protocol development and execution
- Two (2) VHP1000 generators in tandem including manifold piping design and testing

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(Sanford, NC)

IQ/OQ and PQ protocol and cycle development assistance
- Flexible wall sterility test isolators
- VHP1000

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