PHSS Aseptic Processing Workshop Syndicates 2019The PHSS are launching a new annual event in Aseptic processing training with a workshop series delivered as syndicates over a two day event.

Following a key note presentation each day four Hands-on 75min individual workshops will be provided with a total of eight practical workshops providing unique learning opportunities over the two days.

Each Aseptic process workshop is sponsored and delivered by Subject matter experts and specialists on the workshop topic.

Ahead of each workshop syndicate a key note presentation will be provided covering new technologies and challenges in GMP compliance. Workshops will cover current guidance, regulatory expectations and supportive GMP guidance via Q&As, Blogs, Guidance notes.

There is a limit of 80 attendees per day, attendees can attend all workshops over the two days or individual workshop days.

over 25 years of advancing pharmaceutical and healthcare sciences

3rd & 4th April 2019Mere Hotel Golf & Spa Resort, Knutsford, UK£700 + VAT per delegate for two day attendance

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SEE THE KEY NOTES >

SEE THE WORKSHOPS >

NEWANNUALEVENT

OUR SPONSORS

SEE OVER FORKEY NOTES

DAY 1 : 3rd APRIL 2019

DAY 2 : 4th APRIL 2019

Speaker Dr Dieter Bachmann, Director, Aseptic Processing, Johnson & Johnson, Janssen Pharmaceuticals.

Registration from 8.30am – welcome refreshments provided before 9am start.

Keynote Presentation: Aseptic Smart - Robotic Filling – the way of future Pharmaceutical manufacturing• Robotics and Gloveless Barriers in process filling operations – the future.

• Case study Janssen and Pharma Integration Robotic – Gloveless process barrier E2E Modular Aseptic Filling line.

• Considerations in GMP compliance opportunities and challenges, risk reduction in Contamination during filling, EM in Gloveless barriers, Process simulations.

Speaker Gordon Farquharson, Director, Principle Consultant; Critical Systems Ltd. ISO working group leader.

Registration from 8.30am – welcome refreshments provided before 9am start.

Keynote Presentation: ‘’Blind compliance encourages bad science”We are often tempted to ignore the benefits of technology & scientific developments because they challenge the norms, myths and traditions engendered by our GMPs. Our life becomes more complex daily in the light of increasing numbers of regulatory Q&As, Blogs and industry guidance notes. Where do we stand?

KEY NOTE PRESENTATIONS

SEE OVER FORWORKSHOPS

WORKSHOPS

DAY 1 : 3rd APRIL 2019 FOUR 75 MINUTE WORKSHOPS : SESSIONS START 10am

Workshop 1. Moist heat sterilization – autoclaving loads, avoiding wet loads. Considerations of Autoclave cycle design, set-up of cycle/ load, steam quality impact, air removal requirements, temperature management and load placements with impact of protective coverings.

Workshop 2. VHP/ vH2O2 applied to barrier technology, start-up loads or material transfer loads and container closure indirect product contact surfaces in Aseptic process filling including stopper feeder bowls and track-ways. Science and process knowledge to better understand strengths and limitations of VHP/ vH2O2 for improved application, prevention of over claiming efficacy that brings regulatory challenge with consideration to ‘fragility of VHP’ outlined in MHRA Blog. Is VHP/ vH2O2 such a fragile bio-decontamination method or is the knowledge of science and process application of VHP/ vH2O2 bio-decontamination the

real fragility that leads towards poor method application, poor process and GMP non-compliance? What is regulatory expectation over very limited regulatory written guidance?

Workshop 3. Barrier Technology; Isolators and RABS: Good aseptic technique with consideration of ‘First air’ principles including Glove management via selection, integrity testing (visual and physical), response to detected leakage post filling/ aseptic process manipulations in Grade A environments.

Workshop 4. Containment in GMP Aseptic processing applications considering process solutions and containment compliance challenges for API processing as ingredients of sterile aseptic processed products and Aseptic – Containment in Filling of Toxic and biologically hazardous products with Health based exposure limits.

CONTINUES >

WORKSHOPS

DAY 2 : 4th APRIL 2019 FOUR 75 MINUTE WORKSHOPS : SESSIONS START 10am

Workshop 5. Single use Technology in Aseptic processing. Design and Quality considerations. Including Product bag systems, PUPSIT systems and associated connection pathways and barrier technology interfaces.

Workshop 6. Risk based Environmental Monitoring: Setting sample locations by review of contamination risks; considerations on Holistic EM programs and Process monitoring. Considerations on incubation regimes. Demonstration of Rapid Micro Method surface sampling by swabs. Demonstration of Continuous Particle monitoring Contamination GMP Compliance and Event monitoring together with incidence rate trending software.

Workshop 7. Airflow visualisation in controlled zones: CFD (Computational Fluid Dynamics in design), Smoke visualisation studies - good practice in study design and application, LR Method with smoke particle challenge and particle counting tracking to study contamination control.

Workshop 8. Manual Disinfection compliance and application. Current perspective on impact of Annex 1 revision, Biocides directive compliance, disinfectant(s) selection and qualification, Disinfection regimes. Disinfection delivery methods and applications. Managing disinfection residues.

SEE OVER FORGROUPS & TIMINGS

GROUPS & TIMINGS

9.00am9.45am

Key Note: Aseptic Smart Robotic Filling:Future of Sterile Product Manufacturing

10.00am11.15am

11.30am12.45pm

1.30pm2.45pm

3.00pm4.15pm

9.00am9.45am

Key Note: Blind compliance encourages bad Science& Supportive GMP Guidance

10.00am11.15am

11.30am12.45pm

1.30pm2.45pm

3.00pm4.15pm

Red Group:Workshop 1Moist Heat Sterilisation

Red Group:Workshop 5Single use Technologies

Grey Group:Workshop 2VHP/vH202

Grey Group:Workshop 6Risk Based EM

Blue Group:Workshop 3Barrier Technology

Blue Group:Workshop 7Airflow Visualisation

Green Group:Workshop 4Containment in GMP

Green Group:Workshop 8Manual Disinfection

KEY

KEY

DAY 1 : KEY NOTE PRESENTATION & WORKSHOP SYNDICATE

DAY 2 : KEY NOTE PRESENTATION & WORKSHOP SYNDICATE

SEE OVER FORWORKSHOP OUTLINES

WORKSHOP OUTLINES

WORKSHOP 1

Sterilisation via Moist heat is a fundamental process applied in sterile product manufacturing both for equipment-process support materials and products where terminal sterilisation applies. In Aseptic processing the focus is on process equipment sterilisation and process support materials that may include wrapped-protected items or packaged porous loads.

This workshop considers the challenges in cycle design and load presentation to avoid wet loads or wet process equipment surfaces post sterilisation. There are a number of factors that will be considered including steam quality, air removal, temperature equilibration, load presentation and impact of protected packaging.

Sponsor: Agency of Fedegari

Lead Trainer: Alan Heavey, Sterilization Solutions Ltd

Support Trainer: Darren Beckett, SteriTech

SEE OVER FORWORKSHOP 2

Moist Heat Sterilisation

WORKSHOP OUTLINES

WORKSHOP 2

VHP/vH2O2 is widely used in Isolator barrier technology Bio-decontamination and material transfer chambers for surface bio-decontamination of loads. Via the MHRA Blog on ‘’Fragility of VHP’’ the process has come under question and particularly challenged if claimed to be a sterilisation process.

One area that VHP/vH2O2 is applied in filling lines is bio-decontamination of in-direct product contact parts, including Feeder bowls and track-ways, such surfaces require to have

assured sterility and as VHP is not considered a sterilisation process by regulatory authorities then a contamination control strategy has to consider a different approach.

The PHSS have considered the science and process related to assurance of sterility of In-direct product contact surfaces in Aseptic process filling and prepared a Clarity of GMP Guidance note no.1. This guidance and associated science of VHP/ vH2O2: Vaporised Hydrogen Peroxide will be discussed in the workshop.

Sponsor:

Lead Trainer: James Drinkwater, PHSS Chairman, F Ziel GmbH Head of GMP Compliance and Aseptic Processing

Support trainer: Simon Rowlands, STERIS Life Sciences, UK & Ireland

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VHP/ vH2O2 applied to Barrier Technology, Loads and Feeder Bowls

WORKSHOP OUTLINES

WORKSHOP 3

This workshop considers Good aseptic technique in barriers with consideration of ‘First air’ principles.

A practical demonstration shows application of aseptic technique in set-up tasks for installation of a sterilised feeder bowl into an Isolator filling line (following PHSS Clarity in GMP Guidance note no 1) and aseptic technique after Grade A conditions are established and process operations start.

In addition Glove management strategies are presented for Isolators and Restricted Access Barrier systems (RABS) including glove-sleeve selection, integrity testing (visual and physical), and response to detected leakage post filling/ aseptic process manipulations in Grade A environments. Practical demonstration of Wireless lan Glove integrity testing systems with (data integrity) CFR 11 Part 11 compliance.

Sponsors:

Co-Trainers: Dr Dieter Bachmann Director, Aseptic processing J&J: Janssen & Corinna Hinken (Microbiologist), Head of Aseptic Processing Technologies F Ziel GmbH

SEE OVER FORWORKSHOP 4

Barrier Technology; Isolators and RABS

WORKSHOP OUTLINES

WORKSHOP 4

Three aspects of Containment in aseptic processing applications will be considered in this workshop.

• Containment in processing APIs that are ingredients of sterile products aseptically manufactured.

• Aseptic – Containment in filling sterile toxic and biologically hazardous products including Antibody Drug conjugates (ADCs).

• Gowning for personal protection and microbial contamination control in aseptic processing.

Containment is applied at levels with each level encompassing Containment strategies, technologies and compliance methodologies. APIs are typically powder forms that are contained at microgram per cubic metre levels where a SMEPAC

containment test is applied to confirm levels of containment achieved.

Increasingly intermediates and ingredients have to be considered with health based exposure limits where other forms than powders have to be contained e.g. aerosols from an aseptic filling process so new technology solutions and containment test methodologies are required. Highly toxic ADCs and biological products have generated the need for another higher containment level, OEB6, over the traditional 5 levels established in the Pharma industry. This workshop will consider technical solutions for containment at the six OEB6 levels and gowning solutions that support the technical control measures.

Sponsor:

Co-Trainers: Colin Newbould, Wasdell Group Director of Regulatory affairs (toxicologist): processing of APIs, Dr Holger Kranenburg Aseptic – Containment specialist in Aseptic processing technologies department of F Ziel GmbH, John Doyle Product Specialist & Freida Choy Global Strategic Account Manager; DuPont Personal Protection

SEE OVER FORWORKSHOP 5

Containment in GMP Aseptic Processing Applications

WORKSHOP OUTLINES

WORKSHOP 5

The workshop covers ‘Design and Quality’ considerations in single use technology, including Product bag systems, PUPSIT systems and associated connection pathways and barrier technology interfaces.

The implementation of single-use (SU) technology in aseptic processing is steadily increasing to effectively meet the stringent regulatory requirements for the final filtration and filling step.

SU assemblies are pre-configured, pre-sterilized, and ready-to-use which provide benefits like quick process change-over and reduced risk of cross-contamination. As the process conditions are highly dependent on the drug product, batch size,

equipment, and environment, a case by case SU assembly design needs to be developed to be fit for purpose.

The workshop will consider:

• Best design considerations for filtration and filling process

• Technical solutions for integrating into isolator barrier technology

• How to meet the requirement of product filter integrity test, including pre-use post-sterilisation integrity testing (PUPSIT).

• Sterile connections

• The hands on exercise with SU assemblies

Sponsor:

Lead Trainer: Dr Paul Beckett, Merck, Technology Manager EMEA – Filtration

Support Trainer: Dr Simone Biel, Merck, Field Marketing Single Use Systems

SEE OVER FORWORKSHOP 6

Single use Technology in Aseptic Processing

WORKSHOP OUTLINES

WORKSHOP 6

This workshop will consider setting EM sample locations by review of contamination risks; considerations on Holistic EM programs and Process monitoring. Considerations on incubation regimes.

A case study exercise will be set on Environmental monitoring. The PHSS Bio-contamination monograph 20 section on Contamination deviation event management including Root cause analysis and CAPA. Demonstration of Rapid Micro Method surface sampling by swabs (EMS).

Demonstration of Continuous Particle monitoring Contamination GMP Compliance and Event monitoring together with incidence rate trending software (Pharmagraph).

Sponsors:

Lead Trainers: Ian Symonds (ex GSK) Principal GMP Consultant (Microbiologist), Mike Davies (ex GSK) Principal GMP Consultant (Microbiologist)

Demonstrators: Les Dodd & Dave Nolan, EMS Particle Solutions & Janice Wallace, Pharmagraph UK

SEE OVER FORWORKSHOP 7

Risk based Environmental Monitoring (EM)

WORKSHOP OUTLINES

WORKSHOP 7

Airflow protection in Cleanrooms and barrier technologies plays a key role as a contamination control measure. This workshop considers the tools of airflow visualisation to characterise airflow patterns and direction and the increasing requirements in qualification for GMP compliance.

CFD (Computational Fluid Dynamics) will be reviewed as a key design tool with dynamic airflow pattern study that are a precursor to performance and visualisation in smoke studies.

Smoke visualisation studies are a fundamental GMP compliance requirement (Annex 1) with Study design, Study management,

interrogation of results and reports all considered in the workshop.

The LR Method with smoke particle challenge and particle counting tracking to study contamination control performance has increasing application in study of localised airflow protection zones and at barrier technology interfaces between zones. The science behind the (Limitation of Risk) LR Method is discussed together with supporting risk factor calculations. A Case study of qualifying airflow protection in a Isolator Filling line will be shown to show practical application where the LR Method is applied at NTT: No-touch- transfer of pre-sterilised containers into Grade A filling zones.

Sponsor:

Co-Trainers: CFD Pier Angelo Galligani. ASCCA past President. Italian delegate ISO/TC 209 - WG13. Technical Director and Partner & Lapo Galligani SME CFD Techiconsult Firenze S.r.l

Trainer Smoke Studies: Suzanne Nutter QA Manager AstraZeneca (Macclesfield) UK & James Drinkwater Leader of PHSS Aseptic processing & Bio-contamination special interest group

LR Method (Smoke particle challenge – particle counter tracking - risk factor calculations): Professor Bengt Ljungqvist & Assoc. Professor Berit Reinmüller, Chalmers University of Technology, Sweden, Fleur Schnee, F Ziel GmbH

SEE OVER FORWORKSHOP 8

Airflow Visualisation in Controlled Zones

WORKSHOP OUTLINES

WORKSHOP 8

This workshop will cover the current perspective on impact of Annex 1 revision with respect to cleaning and disinfection in contamination control within controlled areas, Biocides directive compliance, disinfectant(s) selection and qualification, Disinfection regimes. Disinfection delivery methods and applications. Managing disinfection residues.

Practical hands-on Cleaning – Disinfection tasks will be applied to demonstrate good practice.

Sponsors:

Co-Trainers

Leader: Matthew Cokely, Ecolab Ltd. Global technical consultant. PHSS Management team

Supporter1: Neil Simpson, Contec Inc

Supporter 2: Elaine Fraser, Veltek Associates Inc

SEE OVERTO BOOK

Manual Disinfection Compliance and Application

VISIT THE PHSS WEBSITE TO BOOK >

Attendance Fee: £700 per delegate to two day attendance.

Shared Attendance (one each day) with colleague: £350 per day.

There is a limit of 80 attendees per day.

Hotel accommodation available at the conference venue: The Mere at special rate via PHSS booking

Don’t miss this opportunity to improve knowledge and applied/ practical skills

in aspects of Aseptic Processing

over 25 years of advancing pharmaceutical and healthcare sciences