2014 asepticmanu brochure

CONFERENCE 1-2 April | EXHIBITION 1-2 April | TRAINING COURSE 3 April

1-2 April 2014IMA Congress Center Bologna | Italy

The Parenteral Drug Association presents...

2014 PDA EuropeTrends in Aseptic Manufacturing

3 April 2014 Training CourseMedia Fills (in Italian Language)

Conference Guide

Welcome from the Co-Chairs

Walter De Matteo, IBSA Co-Chair, President Chapter Italy

Massimo Golia, Co-Chair, Europe Pall

Dear colleagues, The Italian Chapter and the Co-Chairs are delighted to welcome you to the 2014 PDA Europe Trends in Aseptic Manufacturing Meeting in Ozzano dellEmilia, Bologna, Italy! These next two days will provide excellent opportunities to get updated on the latest trends in Aseptic Manufacturing. The meeting covers topics which are of interest to those who deal with manufacturing of parenterals, being in the pharmaceutical industry as a technology provider or in a regulatory function.Management and organizational aspects of facilities, technologies and equipment, and regulatory developments will play a major part in the upcoming presentations. The technical aspects will focus on implementation and practical experiences of single-use systems in manufacturing environments covering facility design, formulation, fill finish operations and aspects of sterility assurance and handling. A case study describes a new facility for bio-tech products with single-use technologies and ready-to-use components. A full session is dedicated to supporting activities of manufacturing like maintenance, cleaning, decontami-nation, monitoring, intervention handling and documentation. In the regulatory session, two presentations from the AIFA and EMA will update you on inspection trends and upcoming new guidelines. The impact of recent guidelines on manufacturing will be discussed from an industry perspective.We look forward to many fruitful and educational discussions. In addition, we will experience a site visit of the IMA Life manufacturing plant and a vendors exhibition.On-site lunch and evening reception provide you with further networking opportunities and with a chance to meet new and old colleagues.For the Italian speaking colleagues, we are happy to offer a post-conference training course on media-fills.

We warmly welcome you to Bologna and wish all of us an informative and enjoyable meeting!

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Information

PDA Contact

Antje PetzholdtRegistration & Membership [email protected]

Event Registration

Membership Management

Interest Group

General Event Information

Melanie DeckerDirector Events & [email protected]

Call for Papers

Presentations

Speaker Biographies

Event Agenda

Committee Information

Elke von Laufenberg Exhibition & Sponsorship [email protected]

Exhibition Information

Sponsoring Opportunities

Scientific Planning Committee

Walter De Matteo, IBSA, Co-Chair, President Chapter Italy

Massimo Golia, Pall Life Sciences, Co-Chair

Michele Arduini, IMA Life

Monica Cervellati, IMA Life

Gabriele Peron, Nuova Ompi

Mauro Giusti, Eli Lilly

Georg Roessling, PDA Europe

Melanie Decker, PDA Europe

2014 PDA Europe

Parenterals4-5 November 2014Munich | Germany

Register by 12 Sep 2014 and SAVE!

europe.pda.org/Parenterals2014

CONFERENCE 4-5 Nov | EXHIBITION 4-5 Nov | TRAINING COURSES 6-7 Nov

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Tuesday, 1 April 20149:00 Welcome & Opening Remarks Georg Roessling,

PDA Europe

9:15 Introduction Walter de Matteo, PDA Chapter President

Session 1: Overview / Current Trends & Observations Moderator: Georg Roessling, PDA Europe

This session addresses management and organizational aspects of a modern parenteral operation to meet product quality and cost requirements.Also considering trends in technological development to support a modern manufac-turing strategy.

9:30 Technical Excellence of Parenteral Manufacturing Mauro Giusti, Eli Lilly

10:15 Questions/Answers and Discussion

10:30 Coffee Break & Exhibition

11:00 Different Filling Systems in Isolator Setup Andr Heinze, Cilag

11:30 100% CCI Inspection Data for Lyophilized Product Vials:Lessons Learned

Derek Duncan, Lighthouse Instruments

12:00 Container Closure Integrity Testing for Parenteral Containers (Vials, Syringes, Ampoules and Polymer Bags)

Marco Renggli, Wilco


12:45 Lunch Break & Exhibition

Session 2: Regulatory Update Moderator: Mauro Guisti, Eli Lilly

The regulatory session gives an update on EMA guidelines as well experiences and observations from regulatory inspections. There will be also an industry perspective which discusses the potential impact of new guidelines on manufacturing activities.

13:45 What s New from EMA Riccardo Luigetti, EMA

14:15 Impact of latest Aseptic Manufacturing Regulations on CMO Aurelia Pocobelli, Corden Pharma



Session 3: Technological Presentation at IMA Plant / Site Visit Moderator: Michele Arduini, IMA Life

In preparation fill finish concepts of IMA will be presented and later at the site there will be the opportunity to see the machines and equipment.

15:30 Isolation Technology HVAC System and Energy Saving Marco Preus, IMA Life

16:00 SITE VISIT @ IMA Life Plant

18:00 End of Day 1

19:15 Networking Event

Agenda


Agenda

Wednesday, 2 April 2014Session 4: Single Use Systems in the Role of Parenteral Manufacturing Moderator: Gabriele Peron, Nuova Ompi

The session is dedicated to Single use Systems in biotech and fill finish manufacturing environment. In five presenta-tions conceptual and practical aspects of single use systems, machinery and ready to use concepts will be presented and discussed. A case study shows recent experiences with a new facility.

9:00 Practical Considerations for Single Use Final Fill Assembly Implementation

Sue Walker, Merck Millipore

9:30 Disposable Filling Technology in Comparison to Common Dosing Processes

Edgar Bauer, Bausch & Stroebel

10:00 Single Use Systems for Formulation and Filling - Design and Validation Solutions

James Barry, Pall Life Sciences


11:00 Enhanced Sterility Assurance in Aseptic Processing thanks to Aseptic Transfer Systems and Single Use Technologies

Matthieu Labedan, Sartorius-Stedim

11:30 A Biotech user Perspective on "Ready to use Solutions for Filling" (SUS - presterilised vials)

Flavio Brambilla, Adienne Stefano Lazzarini, Pall Life Sciences Andrea Cecchetto, Nuova Ompi


12:30 Lunch Break & Exhibition

Session 5: Cleaning, Monitoring and Documentation Moderator: Massimo Golia, Pall Life Sciences

An important part of a successful manufacturing facility are the activities of maintenance, cleaning, bio-decontam-ination, monitoring, intervention handling, and documentation. These activities are crucial to produce sustainable product quality therefore it will be covered in this session. A panel discussion addressing technical, managerial and regulatory aspects will highlight this session.

13:30 Criteria to Select a Flexible Filling Line for a Pilot Plant Dimitri Joris, Pfizer

13:45 Cleaning Validation Giovanni Vitali, CTP

14:15 Modern Concepts of Environmental Monitoring Gilberto Dalmaso, Particle Measuring Systems



15:45 Visual Inspection- From Regulation to Technology Emanuele Cudiferro, Brevetti C.E.A.

16:15 Documentation Issues related to Equipment and its Suppliers Simone Villani, CTP

16:45 Chemical Surface Bio-Decontamination: Key Factors Valentina Viscusi Sergio Mauri, Fedegari

17:15 Q&A, Discussion

17:30 Closing Remarks Georg Roessling, PDA Europe

17:35 End of the Conference

https://europe.pda.org/Vaccines2014


29-30 April 2014Courtyard by Marriott HotelBrussels | Belgium

WORKSHOP 29-30 April | EXHIBIT ION 29-30 April

Applying QbD Principles to complex biologics based on the A-Vax Model

2014 PDA Europe Workshop

Vaccines & Beyond


Networking Dinner

PDA and IMA Life are pleased to invite you for a great evening at the I Portici Hotel in Bologna.

INVITATION

Meet with all conference attendees in this original atmosphere and network while you relax.

We kindly ask you to confirm your attendance directly at the PDA Registration Desk.

Location:I Portici Hotel Bologna

Via Indipendenza, 6940121 Bologna

Tel. +39 051 42185Fax +39 051 4218550www.iporticihotel.com/en/i-portici-hotel-bologna

Date: Tuesday,

1 April 2014

Meeting Point: Hotel Lobby

I Portici Hotel Bologna at 19:45

Bus shuttle from IMA Life leaving at 18:15 after the Site Visit

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IMAPDA

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Bausch +Strbel

NuovaOmpi

Afton

MerckMillipore

Lighthouse

ConferenceRoom

Poster Area

Poster Area

2014 PDA Europe Trends in Aseptic ManufacturingConference, Exhibition1-2 April 2014 | Bologna | Italy

Table Top 3m x 2m (6m2)

Floor Plan


Afton Scientific, LLC 2020 Avon Court Charlottesville Virginia 22902, USA Tel: +1 434 979 373 7 Fax: +1 434 979 373 8 [email protected] www.aftonscientific.com

cGMP Processing of Sterile Products Afton Scientific

Afton Scientific provides cGMP contract sterile filling services of investigative new drugs, biologics and commercial inject-able pharmaceuticals. Afton also prepares and ships pre-pack-aged sterile empty vials (Ready-to-Fill) to companies world-wide for immediate use in cGMP filling operations. Afton's customers include small biotechs, multinational pharmaceuti-cal companies and major research institutions.

Bausch + Strbel Maschinenfabrik Ilshofen GmbH + Co. KG Parkstr. 1 74532 Ilshofen Germany Tel: +49 7904 70 10 Fax: +49 7904 70 12 22 [email protected] www.bausch-stroebel.com

The Bausch + Strbel product range specializes in machines for pharmaceutical primary packaging, including equipment for washing, sterilising/depyrogenating, filling, closing and labelling of containers such as ampoules, cartridges, dispos-able syringes, vials and bottles of all kinds. Our systems are designed to comply with the latest FDA and GMP require-ments and are available for all capacity ranges, starting from process development and clinical batches to fully integrated commercial production.

LIGHTHOUSE Instruments Science Park 408 1098 XH Amsterdam The Netherlands Tel: +31 6 20 17 65 02 [email protected] www.lighthouseinstruments.com

LIGHTHOUSE is the leading global provider of laser-based, non-destructive headspace inspection systems. Headspace applications include among others: automated 100% con-tainer closure inspection, container closure validation stud-ies, headspace microbial studies, in-process monitoring of oxygen during filling and for stability studies, lyo cycle opti-mization, and lyo chamber moisture mapping. LIGHTHOUSE offers a range of benchtop and in-line platforms with patent-ed laser sensor technology commercialized with the help of funding from the Food and Drug Administration. In addition, headspace measurement services are delivered from labora-tory facilities in Amsterdam and Charlottesville, Virginia.

Merck Millipore 39 Route Industrielle de la Hardt 67120 Molsheim France T: +33 3 90 46 90 00 F: +33 3 90 46 91 90 [email protected] www.merckmillipore.com

As a division of Merck KGaA of Germany, Merck Millipore offers a broad spectrum of proven tools and technolo-gies, together with performance solutions innovations, dedicated to helping our customers succeed in the re-search, development and production of biotechnology and pharmaceutical drug therapies. Comprised of three business units Bioscience, Lab Solutions, and Process Solutions Merck Millipore is a top tier supplier to the life science industry, and serves as a strategic partner for scientists, engineers, and researchers. Headquartered in Billerica, Massachusetts, Merck Millipore has around 10,000 employees in 67 countries motivated by the po-tential of science for life through a portfolio of more than 40,000 products.

Nuova Ompi - Stevanato Group Via Molinella, 17 35017 Piombino Dese (PD) Italy Tel: +39 049 931 81 11 Fax: +39 049 936 61 51 [email protected] www.stevanatogroup.com

Nuova Ompi produces pharmaceutical glass primary packag-ing for injectable use. Founded in 1949, it is also known in the glass tube forming technology and machinery sector. It is a world leader in the production of insulin cartridges as well as the undisputed international leader in the production of glass containers for pharmaceutical use (vials, cartridges, ampoules and syringes). The Group provides a full range of pharmaceutical glass tube products with the highest levels of quality and it is a partner of leading global pharmaceuti-cal companies.

To Exhibit:

Exhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your companys products or services become a valuable tool or resource for our attendees.

For exhibition information please contact:

Elke von LaufenbergExhibition & Sponsorship Manager PDA EuropeTel: +49 (0) 33056 - 23 77 14Email: [email protected]

CONFERENCE 24-25 June | EXHIBIT ION 24-25 June | TRAINING COURSES 26-27 June

24-25 June 2014Hotel Sheraton MaslakIstanbul | Turkey


https://europe.pda.org/ParMan2014

2014 PDA EuropeParenteral Manufacturing

26 June: One-Day Training Courses Cleaning & Disinfection Fill & Finish Operations for Parenterals GMP and Quality Systems for Parenterals Technology Transfer PDA Technical Report 3026-27 June: Two-Day Training Course Environmental ControlFor further informations please visit our website.


PDA Europe Upcoming Activities and Events 2014

29-30 April Workshop, Exhibition Vaccines & BeyondBrussels Belgium

2-6 JunePre-conference Workshop, Conference, Exhibition, Training Course

Advanced Therapy Medicinal Products

Madrid Spain

24-27 June Conference, Exhibition, Training Courses Parenteral ManufacturingIstanbul Turkey

15-19 SeptemberPre-conference Workshop, Conference, Exhibition, Training Courses

Pharmaceutical Freeze Drying Technology

Brussels Belgium

18-19 September Training Course PDA/PICs API Training CourseBrussels Belgium

23-26 SeptemberPre-Workshop, Workshop, Exhibition, Training Courses

7th Workshop on Monoclonal Antibodies

Basel Switzerland

29-30 September Conference, Exhibition MycoplasmaBerlinGermany

14-17 October Conference, Exhibition, Training CoursePharmaceutical Cold & Supply Chain Logistics

BerlinGermany

21-24 October Conference, Exhibition, Training Course Visual Inspection ForumBerlinGermany

4-7 November Conference, Exhibition, Training Courses ParenteralsMunichGermany

2-4 December Conference, Exhibition, Training Course Outsourcing/Contract ManufacturingBerlinGermany

For latest info: europe.pda.org Subject to change Shortlist 2014-03-18

Get a quick survey of all PDA Europe activities with the myPDA-WebAppFor Apple iPhone & iPad, Android and Windows Mobile7 smartphones: www.my-pda.eu

Additional training courses will accompany most conferences. For details, please got to www.europe.pda.org

For general informationFor general informationplease contact:

PDA Europe, Adalbertstr. 916548 Glienicke / Berlin, GermanyTel: +49 (0) 33056 - 23 77 10Fax: +49 (0) 33056 - 23 77 77Email: [email protected]

For exhibition informationFor exhibition informationplease contact:please contact:

Elke von LaufenbergExhibition & Sponsorship Manager Exhibition & Sponsorship Manager PDA EuropeTel: + 49 (0) 33056 - 23 77 14Email: [email protected]

2014PDA_Fullpage_EventAd_EU.indd 1 18.03.14 13:16

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2014 asepticmanu brochure

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