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2019PharmaProduct-Japan-1988x680-2

2019 PDA Pharmaceutical Product Quality Testing Conference

Oct 29 - Oct 30, 2019
Tokyo, Japan

Visual Inspection and Container Closure Integrity

  • Conference
  • Asia-Pacific
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Program Highlights

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Come as a group and bring along a colleague for FREE!
Register 3 people from the same organization as a group (at the same time) for the Conference and receive the 4th registration free.

Overview

A fill-finish process for injectable products must ensure that the formulation is accurately filled into the container (e.g., ampoule, vial, syringe, bag) and the container must protect the product throughout its shelf life. The container should be filled without addition of foreign particles and sealed without damage that would affect container integrity.

This conference will highlight ways to meet these important objectives:

  • Current global regulations and compendial requirements
  • Technology update for visual inspection and container integrity testing
  • Best development and routine manufacturing practices
  • Case studies (practical lessons-learned)
  • Q&A, panel discussions

Speaking Opportunities

Georg Roessling, PhD
Sr. Consultant Business
Email: [email protected]

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Agenda

  • Day 1
  • Day 2

  • Tuesday, 29 October

    *Agenda is subject to change*

    08:00 - 17:00
    Registration Open

    08:00 - 09:00
    Continental Breakfast

    09:00 - 09:05
    Opening Remarks
    Georg Roessling, PhD,     Senior Consultant, Business Development Asia, PDA

    09:05 - 14:10
    P1: Inspection Trends Based on Region
    This session will give an overview on regulatory and compendial developments and trends on the topics of visual inspection and container integrity globally with a focus on the regions Japan/Asia-Pacific, Europe and the USA. Industry experts will share their positions on these developments.
    Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

    09:05 - 09:30
    Regulator's View on Up-Grading Guidance for Visual Inspection and Container Integrity 
    Tetsuhito Takarada, Expert, Pharmaceutical and Medical Device Agency

    09:30 - 09:55
    New General Information on Package Integrity Evaluation of Sterile Pharmaceutical Products in Japanese Pharmacopeia
    Ken-ichi Izutsu, PhD, Chair of JP WG, Head of Test Method Group, National Institute of Health Sciences (NIHS)

    09:55 - 10:25
    ICH Q2, Q14; Its Influence to Container Integrity and Visual Inspection
    Yukio Hiyama, PhD, Visiting Scientist, National Institute of Health Sciences (NIHS)

    10:25 - 11:00
    Industry Perspective on Visual Inspection and Container Closure
    Hirohito Katayama, PhD, PDA Sterile Product Task Force (Japan), Bayer Yakuhin Ltd.

    11:00 - 11:30
    Coffee Break and Exhibition

    11:30 - 14:10
    P1: Inspection Trends Based on Region CONTINUED
    This session will give an overview on regulatory and compendial developments and trends on the topics of visual inspection and container integrity globally with a focus on the regions Japan/Asia-Pacific, Europe and the USA. Industry experts will share their positions on these developments.
    Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

    11:30 - 12:20
    Regulatory (FDA) and Compendial (USP) Updates from the USA
    John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    12:20 - 13:20
    Networking Lunch

    13:20 - 14:10
    P1: Inspection Trends Based on Region CONTINUED
    This session will give an overview on regulatory and compendial developments and trends on the topics of visual inspection and container integrity globally with a focus on the regions Japan/Asia-Pacific, Europe and the USA. Industry experts will share their positions on these developments.
    Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

    13:20 - 14:10
    Visual Inspection & Container Integrity – European Considerations
    Hanns-Christian Mahler, Prof., Head of Drug Product Services, Lonza AG

    14:10 - 15:00
    P2: Summary of TR79 - Difficult to Inspect Products
    This presentation will summarize the PDA Technical Report on "Difficult to Inspect Products". These are products which can be turbid, colored or have challenges which need different approaches for inspection.
    Moderator: Hanns-Christian Mahler, PhD, Prof., Head of Drug Product Services, Lonza AG

    14:10 - 14:40
    PDA Technical Report 79: Particulate Matter Control in Difficult to Inspect Parenterals
    John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    14:40 - 15:00
    Questions and Answers/Discussion

    15:00 - 15:30
    Coffee Break and Exhibition

    15:30 - 18:20
    P3: Tech Update on Visual Inspection Technologies
    This session will give an overview of new technical developments and best industry practices of visual inspection of injectable products. Equipment, machines, new procedures and concepts of visual inspection will be presented.
    Moderator: John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    15:30 - 16:20
    Automatic Visual Inspection of Lyophilized Products, Characterizes as Difficult to Inspect Products (DIP), with Very Low False Reject
    Andrea Sardella, PhD, Pharma Inspection Product Development Manager, Stevanato Group Engineering Systems

    16:20 - 17:10
    Deep Learning for Visual Inspection - Implementation in Automated Inspection Machine Under Production Conditions
    Jose Zanardi, Senior Manager, Engineering Vision Technology, Bosch Packaging Technology K. K.

    17:10 - 18:00
    Spectral-coded Illumination for Reliable Differentiation Between Transparent Particles and Air Bubbles
    Stefan Stehling, Sales Manager, Inspection Applications, Seidenader Maschinenbau GmbH

    18:00 - 18:20
    Questions and Answers/Discussion

    18:20 - 20:30
    Networking Reception


  • Wednesday, 30 October

    *Agenda is subject to change*

    08:00 - 17:00
    Registration Open

    08:00 - 09:00
    Continental Breakfast

    09:00 - 10:15
    P4: Elements of a Good Visual Inspection Process
    This session will present best practice of manual and automatic inspection. Main topics of the session will be on selection, qualification and training of personnel, defect library, establishing of the whole inspection process. 
    Moderator: Yukio Hiyama, PhD, Visiting Scientist, National Institute of Health Sciences (NIHS)

    09:00 - 09:20
    Managing a Globally Compliant Visual Inspection Program
    John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    09:20 – 10:00
    Current Industrial Practices of Visual Inspection in Japan and Qualification of Detectability on Visual Inspaction Operator
    Satomi Okano,     PDA Sterile Product Task Force (Japan), Bayer Yakuhin, Ltd.

    10:00 - 10:15
    Questions and Answers/Discussion

    10:15 - 10:45
    Coffee Break and Exhibition

    10:45 - 12:15
    P5: What Does A Good Container Integrity Program Look Like?
    This session will present best industry practice and share the relevant elements which need to be considered when selecting a container closure system and the right test method.
    Moderator: Ken-ichi Izutsu, PhD, Head of Test Method Group, National Institute of Health Sciences (NIHS)

    10:45 - 11:30
    Practices of Container Integrity in Japan
    Tohru Ogawa,     PDA Sterile Product Task Force (Japan), Daiichi Sankyo CO. Ltd.

    Qualification of Test Methods: Leak Simulation and Flow Test
    Kimitaka Misawa,     PDA Sterile Product Task Force (Japan), Nagase Medicals CO. Ltd.

    11:30 - 12:00
    Qualification of Test Methods: Leak Simulation and Flow Test
    Henry Lu,     Optek

    12:00 - 12:15
    Questions and Answers/Discussion

    12:15 - 13:15
    Networking Lunch

    13:15 - 15:30
    P6: Tech Update on Container Integrity
    The selection of the right container closure components, the validation and the continuous testing of their suitability in production is very important. Different container types and products require special test methods. Therefore, it is most important to select the most suitable method. This session gives an overview of technologies, equipment and test procedures of container integrity measurement systems.
    Moderator: Hirohito Katayama, PhD, Head of Product Supply Japan, Bayer Yakuhin Ltd.

    13150 - 14:05
    Implementing Robust CCIT Practices Throughout the Product Life Cycle
    Derek Duncan PhD, Director Product Line Europe, Lighthouse Instruments

    14:05 - 14:55
    Applications and Strategies for Deploying High Voltage Leak Detection
    Heinz Wolf, PTI - Packaging Technologies & Inspection

    14:55 - 15:30
    Unique Identification of Glass Containers Throughout the Manufacturing Process: The Benefits of Glass Marking During the Automatic Inspection of Filled Containers
    Tod Urquhart, Stevanato Group

    15:30 - 15:45
    Questions and Answers/Discussion
    15:45 - 16:15 
    Coffee Break and Exhibition

    16:15 - 16:50
    P7: Case Study on Container Integrity
    Moderator: Hirohito Katayama, PhD,     Head of Product Supply Japan, Bayer Yakuhin Ltd.

    16:15 | CCIT Blue Dye Ingress Test: Influence of Product Viscosity on Detection Rate
    Moli Wan, Vetter-Pharma

    16:50 - 17:30
    P8: Q&A Panel Discussion with Prepared Questions

    Moderators: Hirohito Katayama PhD, Head of Product Supply Japan, Bayer Yakuhin Ltd. and 
    John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    Visual Inspection:

    What is meant by “readily detectable”, “essentially free” or “practically free” when applied to visual inspection?
    How can we monitor and trend inspection performance?
    How do you create and use a defect library?
    Is automated inspection better than manual inspection?  When should you consider using automated inspection?

    Container Integrity:
    Are dye and microbial ingress tests still accepted?
    What is a leak?  What leak rate is acceptable?
    How often do I have to revalidate the method?

    Visual Inspection:
    What is meant by “readily detectable”, “essentially free” or “practically free” when applied to visual inspection?
    How to handle detected foreign particle
    How differentiate country level customer needs? And how align them to a global standard?
    How can we monitor and trend inspection performance?
    How do you create and use a defect library?
    Is automated inspection better than manual inspection?  When should you consider using automated inspection?

    Panelists:

    • Hanns-Christian Mahler PhD, Prof., Head of Drug Product Services, Lonza AG
    • Andrea Sardella PhD, Pharma Inspection Product Development Manager, Stevanato Group Engineering Systems
    • Jose Zanardi, Senior Manager, Engineering Vision Technology, Bosch Packaging Technology K.K.
    • Derek Duncan PhD, Director Product Line Europe, Lighthouse Instruments
    • Heinz Wolf, PTI - Packaging Technologies & Inspection
    • Tod Urquhart, Stevanato Group
    • Moli Wan, Vetter-Pharma
    • Henry Lu, Optek
    • Ken-ichi Izutsu, PhD, Chair of JP WG, Head of Test Method Group, National Institute of Health Sciences (NIHS)
    • Manabu Tsuda, PDA Sterile Product Task Force (Japan), Mitsubishi Tanabe Pharma Corporation
    • Satomi Okano, PDA Sterile Product Task Force (Japan), Bayer Yakuhin, Ltd.

    17:30
    Closing Remarks
    Georg Roessling, PhD    , Senior Consultant, Business Development Asia, PDA



Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

Got a Question? We have answers

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sheraton Miyako Hotel Tokyo

1 Chome-1-50 Shirokanedai
Tokyo, Japan

Make a Reservation
Sheraton Miyako Hotel Tokyo
  • Accommodations

    A block of rooms have been reserved for meeting participants.  The rate is $30,450 JPY  inclusive of taxes and breakfast.  Reservations must be secured by Saturday, October 5, 2019.  After this date, reservation can be made on a space and rate available basis only.

    To reserve a room at the discounted group rate please use the following link:
    https://advance.reservation.jp/miyakohotels/stay_pc/rsv/cc_pln_dtl_redirect.aspx?cp=2&lang=en-US&hi_id=1&smp_id=935&cp_id=2019APRC&is_cal=True

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

    Letter of Invitation

    If you are requesting an invitation letter please note that you are required to complete the registration process including the final payment before the letter can be provided.  Please email [email protected] to request a letter of invitation. 

  • Amenities

    The Guest room interiors of dark wood are designed with a simple elegance. Every room is equipped with a high-speed Internet connection for business, and "Sheraton Signature Sleep Experience" bed that leads guests to deep and comfortable sleep. Very genuine hospitality.

    * Check-in time 3:00pm, Check-out time 12:00pm.
    * Free High Speed Internet connection and Wi-Fi is available in all guestrooms.

    Comfort Superior for inclusive of daily breakfast.
    You can choose one from these three restaurants.
    * "Cafe California": Set Menu (07:00-10:30)
    * "Shisen": Buffet (06:30-10:00)

How to Get Here

By Air

From Narita Airport

By Limousine Bus
Narita Airport → (Limousine bus: Approx. 120 min) → Hotel
Limousine Bus Fares

Adult (Junior high student or older) 3,100 JPY
Child (Elementary school student or younger) 1,550 JPY

From Haneda Airport

By Limousine Bus
Haneda Airport → (Limousine bus: Approx. 75 min) → Hotel

Adult (Junior high student or older) 820 JPY
Child (Elementary school student or younger) 410 JPY

By Car

By Tokyo City Bus

Journey time: Approx. 5 min

  • For the journey from Meguro Station to the hotel by the Tokyo City Bus, take a bus bound for Ooi-keibajo (Ooi Racetrack) <Line Shina 93> and get off at the Shirokanedai Station bus stop.
  • For the journey from Shinagawa Station to the hotel by the Tokyo City Bus, take a bus bound for Meguro Station <Line Shina 93> and get off at the Shirokanedai Station bus stop.

Other Options

By Train

Train
Shinagawa Station → (JR Yamanote Line 160 JPY/8 min) → Meguro Station → (Subway 170 JPY/2 min) → Shirokanedai Station → (Approx. 4 min walk) → Hotel

Taxi
From Shinagawa Station Approx. 7 min/Approx. 1,100 JPY
From Meguro Station Approx. 5 min/Approx. 730 JPY

From Station

Hotel Shuttle Bus
The hotel also serves a free shuttle bus on these routes in some time periods of a day. Please see the below
“Hotel Shuttle Bus” description.

Journey time: Meguro Station Approx. 5 min
Journey time: Shinagawa Station Approx. 7 min

  • Meguro Station ←→ Sheraton Miyako Hotel Tokyo
  • Sheraton Miyako Hotel Tokyo → Shinagawa Station

Directions

Registration Fees

Regular Price
Registration Type  
Conference
Member $699 USD
Non-member $899 USD
Government $399 USD
Student $399 USD
Young Professional Member $399 USD

Letter of Invitation

If you are requesting an invitation letter please note that you are required to complete the registration process including the final payment before the letter can be provided.  Please email [email protected] to request a letter of invitation. 







* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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