“Isolator Procurement for

Small to Medium
Enterprises"
Presented by Charles Ross, August 2018

Slide 1 © PharmOut 2018

Agenda

Project

Why an isolator

Procurement

URS key considerations

The players

Slide 2 © PharmOut 2018

Project Initiation

• Project
• Establishment of a MTP competency based, manufacturing skills development
facility and early stage clinical trial manufacturing facility.

• Consortium of Vaxxas, TRI, PharmOut and Eurofins ams.

• Key User Requirements

• Training – bells & whistles

• Manufacturing - flexibility

Slide 3 © PharmOut 2018

Isolator Tech

Slide 4 © PharmOut 2018

Why an isolator

• URS 1 -Training
• Technology of the future
• Stricter regulations/improve patient safety
• Growth in small scale personalised medicines

• URS 2 -Manufacturing
• Manufacturing flexibility and turnaround
• Containment and aseptic
• Increased capital but reduced operation costs – less enviros, no aseptic
gowning etc
• Australia biotech growth (CTN and tax credit)

Slide 5 © PharmOut 2018

Procurement
Validation V-Model Validation Validation
(Master) Plan (Summary) Report
• URS Development
• Know your product User Requirement
Verifies
Performance
Specification Qualification
• Get help and do research
• Be prepared, i.e. URS version control Functional
Verifies
Operation
Specification Qualification
Design
Qualification
• Issue for tender Design
Verifies
Installation
Specification Qualification
• Have a good filing system to track responses
• Draft URS to suit the DQ/tender comparison Build/Purchase
Commissioning/
FAT/SAT

• Collate & tender comparison (DQ stage 1)

• Down-select and negotiate

Slide 6 © PharmOut 2018

Key URS Considerations

General
• Containment or aseptic (+/- pressure) or both
• Access – maintenance and cleaning
• Integrated filling systems
• Removable/customisable flanges (future proof)

Material Handling
• Batch cycle time
• RTP and rapid decon chambers
• Internal fitout – hooks, shelves….
• Materials in/out (components, liquid & waste)
• Glove port position (wooden mock up)

Slide 7 © PharmOut 2018

Key URS Considerations

Decontamination Exhaust
HEPA
Supply
HEPA

• Open or closed loop VHP system

• HEPA & workspace decontamination
• Proprietary or in-house system
Main HEPA

• Speed of decontamination
• Cycle control Is olator
Work space

Return HEPA
• OHSE
Grade A

HVAC
• Laminar flow, HPF, return air HEPA filters, BiBo systems
• Leakage rate (ISO14644)
• Environment temp/humidity control

Slide 8 © PharmOut 2018

Key URS Considerations
Compliance
• GAMP5 & 21CFRpart11
• ISO14644
• PIC/S

Consumables
• HEPAs
• Dehumidifying filters
• H2O2
• Seals

Slide 9 © PharmOut 2018

Key URS Considerations

Other
• Wireless glove testing
• Integrated EMS
• Glove type & material
• Material compatibility

Slide 10 © PharmOut 2018

Installation and validation considerations

Installation
• Size up to 2.7m tall and weight 2.5t
• Utilities VHP exhaust, chilled water, compressed air and power
• OHS – VHP sensors

Validation
• FAT, IQ & OQ
• PQ Cycle development – ($$)
• Training

Other
• After sales service
• Spare parts and warranty
Slide 11 © PharmOut 2018
The Players

High end: M+P (Optima), Skan, IMA Life, Steriline…..

• Aesthetic & detailed

• High level of compliance

• Fully integrated

• $750k+

Slide 12 © PharmOut 2018

Key considerations

Mid/High: TEMA Sinergie, Comecer, Getinge…..

• Nuclear medicine

• Medium priced (approx. $500k)

Slide 13 © PharmOut 2018

Key considerations

Dark horse: Bioquell…..

• Plastic (VHP compatible)

• Fully modular

• Inexpensive

• $300k

Slide 14 © PharmOut 2018

Thanks and questions?

Charles Ross
Vaxxas – Clinical Operations

cross@vaxxas.com
www.vaxxas.com

Slide 15 © PharmOut 2018