2800 Mechelen - ISPE and Chapters... · 11:00 - 11:35 HVAC influencing the performance of cleanroom...

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Best practices in Aseptic Processing Challenges, Solutions and site visits With table top exhibitions, Alcon and Pfizer Puurs site visits When Wednesday 22 November 2017 Location Technopolis Technologielaan 1 2800 Mechelen A visit of Alcon and Pfizer in Puurs will be organised in the afternoon Table tops will be accessible during the seminar

Transcript of 2800 Mechelen - ISPE and Chapters... · 11:00 - 11:35 HVAC influencing the performance of cleanroom...

Page 1: 2800 Mechelen - ISPE and Chapters... · 11:00 - 11:35 HVAC influencing the performance of cleanroom containment equipment ... 295 € (for Non ISPE member –Young Professional (age

Best practices in Aseptic Processing

Challenges, Solutions and site visits

With table top exhibitions, Alcon and Pfizer Puurs site visits

When Wednesday 22 November 2017

Location Technopolis Technologielaan 1 2800 Mechelen

A visit of Alcon and Pfizer in Puurs will be organised in the afternoon

Table tops will be accessible during the seminar

Page 2: 2800 Mechelen - ISPE and Chapters... · 11:00 - 11:35 HVAC influencing the performance of cleanroom containment equipment ... 295 € (for Non ISPE member –Young Professional (age

8:00 - 8:45 Registration and coffee 8:45 - 8:55 Welcome (Jef De Clercq, President ISPE Belgium Affiliate )

8:55 – 9:20 Keynote speech : New Revised EU Annex 1 : what’s new ? (Marc Besson, A3P)

9:20 - 9:55 Aseptic Training and Grade B gowning improvement (Sarah Dewulf & Vanessa Smeyers, Pfizer )

9:55 - 10:30 VHP and Hydrogen peroxide nebulization processes for Isolator technologies (Patrick Vanhecke, GSK)

10:30 - 11:00 Coffee break with table top & networking opportunities

11:00 - 11:35 HVAC influencing the performance of cleanroom containment equipment (Mario Don Porto Carero, J&J)

11:35 - 12:10 Current standards on Smoke Studies and Process (Media) Simulation (Geert Vandenbossche, Novartis)

12:10 - 13:40 Lunch with table top & networking opportunities

13:40 - 14:15 Rabs gloves integrity testing (Gert Viville, J&J)

14:15 – 14:50 Aseptic management of Freeze-dryers in pharmaceutical industry, a risk based approach (Charles Mees, GSK)

14:50 – 15:25 Reducing risks with automated aseptic processing filling (Guy Matthews, Parker)

15:25 - 18:30 Alcon & Pfizer Visits (including transfers by bus)

Alcon Visit Pfizer Visit

18:30 Closing of the day with networking reception

Best practices in Aseptic Processing

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Abstracts

KEYNOTE : New Revised EU Annex 1 : what’s new ?(Marc BESSON)

The EMA Inspection working group and PIC/S have published a new version of the EU Annex 1. The revised guideline is intended to:

• clarify to what extent Q9 and Q10 should be followed in the design and implementation of facilities, equipment and processes for

the manufacture of sterile medicinal products.

• clarify requirements for the use of new technologies (closed systems, single use systems, BFS…)

• correct inaccuracies of the current version and offer more details to remove ambiguity and to give clearer interpretation of GMP

expectations

The presentation will aim to highlight key changes and try to anticipate consequences for the Pharma industry

Aseptic Training and Grade B gowning improvement(Sarah Dewulf & Vanessa Smeyers)

Cleanroom contamination can be traced back to a number of sources. Most contamination within the aseptic processing area is

caused by the humans working in the cleanrooms. An important factor in minimizing the risk on microbiological contamination of the

cleanroom, are qualitative and easy-to-use gowning items and procedures. Some of the recent gowning improvements, implemented

at Pfizer Puurs, will be explained, as well as the training principles and new aseptic training center used to train aseptic behaviors.

VHP and Hydrogen peroxide nebulization processes for Isolator technologies (Patrick Vanhecke)

This presentation will compare classical VHP process and H2O2 nebulization applied to isolator technology and the associated isolator

design.

GSK Vaccines case studies will present the advantages / disadvantages of both technologies.

HVAC influencing the performance of cleanroom containment equipment (Mario Don Porto Carero)

Based upon smoke studies and CFD (computational fluid dynamics) the influence of room ventilation on LAF, RABS and LEV

performance will be analyzed during this session. Also the negative impact of equipment with high heat load on your qualification

testing will be clarified.

Case study 1 : How a direct AHU supply to a RABS plenum promotes room ventilation efficiency and operator comfort.

Case study 2 : It is not always safe to use a Bio Safety Cabinet.

Current standards on Smoke Studies and Process (Media) Simulation (Geert Vandenbossche)

Smoke Studies

• The presentation will share insights in the evaluation on inspectors expectations when reviewing smoke studies.

• Actual examples of technical and procedural upgrades before and after will be shared

Media Simulation

• Key upgrades to the program as triggered by recent FDA inspections as well as Annex-1 updates will be highlighted.

• What are the most current expectations?”

Best practices in Aseptic Processing

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Abstracts

Rabs Gloves Integrity Testing(Gert Viville)

Glove integrity testing has been profoundly discussed and numerous articles have been written on this topic. In 2008 Annex 1 to EU

reiterated the importance of having glove integrity testing for isolators by stating: “Monitoring should be carried out routinely and

should include frequent leak testing of the isolator and glove/sleeve system.”

In recent inspections, auditors are now starting the request to use automated glove leak testing for restricted access barrier systems

(RABS). This presentation enforces the importance of performing glove integrity testing, but also highlights the difference in risk level

between isolators and RABS, both from the perspective of the potential contamination of the internal environment of the isolator /

RABS as from the perspective of the contamination of the external environment.

While glove integrity testing is of the utmost importance, in case of a RABS, a visual inspection integrity test linked to a comprehensive

training program can be selected. Technology on glove leak testing is however evolving and “in situ” test equipment is becoming

available which can be used within a Grade B cleanroom.

Aseptic management of Freeze-dryers in pharmaceutical industry, a risk based approach (Charles Mees)

Freeze-dryer sterilization is a hot topic for the pharmaceutical industry. Sterilization of freeze-dryers is mandatory, but will have an

impact on the reliability of the equipment in the long term. The purpose of this session is to present a methodology to support the

sterilization frequency based on a risk assessment taking into account the aseptic practice surrounding the activity and the

technologies used.

Reducing risks with automated aseptic processing filling(Guy Matthews)

By combining single use automation and a thorough understanding of the materials of construction, Parker has built an automated

pack off system for the shipping of bulk product. The benefits of this solution will be discuss from a process quality, standardisation

and cost point of view.

The presentation will highlight the importance concerning the selection of materials of construction by looking at how materials perform

throughout the supply chain, not just at the point of fill. There will be a focus on one part of the assembly, namely the bottle and all of

its components. The importance of understanding how materials behave at different temperatures and how this can impact process

security with a focus on bottle integrity will be discuss.

By the application of single use automation and the correct selection of materials for this process, it has been possible to create a

solution that ensures the product integrity during the shipping process.

Best practices in Aseptic Processing

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Who should attend?

All stakeholders responsible for:

• Research & Development

• Clinical trials manufacturing and scale up

• Manufacturing & Quality Control

• Technology & Engineering & Automation

• Logistics & Distribution

• Supply Chain

• Regulatory, validation, QA & GMP

and active in:

• Pharmaceuticals

• Biopharmaceuticals

• Biologics

• API

• And related Life Science industries…

Registration

• Open for ISPE Members or Non-ISPE Members

• Registration required (before 21 November) via website : https://www.ispe2017seminar.be/

• Including Lunch and Networking and transport by bus

• Price :

350 € (for ISPE member)

75 € (for ISPE member – Young Professional (age under 30))

600 € (for Non ISPE Member, including 1 year membership)

295 € (for Non ISPE member – Young Professional (age under 30), including 1 year membership)

• See registration website for payment details.

Contact : [email protected]

ISPE reserves the right to delay the meeting and modify the program and the place, in case of force majeure.

Any cancellation received later than one week before the event will not be credited.

Best practices in Aseptic Processing

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TechnopolisTechnologielaan 12800 Mechelen

By Car

Via the motorway: Technopolis is located next to the E19 (Brussels-Antwerp). Take exit 10 Mechelen-Zuid and you will directly enter a big, free parking area.

Are you coming from the ring road of Mechelen? Follow the direction of Mechelen Central Station. When you get to the Central Station, drive over the viaduct in the direction of the E19. Just before the on-ramp to the motorway, you will see Technopolis.

TExte

Best practices in Aseptic Processing

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Table Tops

Best practices in Aseptic Processing

Sponsors

Site Visit

Page 8: 2800 Mechelen - ISPE and Chapters... · 11:00 - 11:35 HVAC influencing the performance of cleanroom containment equipment ... 295 € (for Non ISPE member –Young Professional (age