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2019 GlassContainer

Best Practices for Glass Primary Containers

Oct 09 - Oct 10, 2019
Mainz, Germany

This two-day course will offer insights into the science of glass and its inherent properties. It will review container design and dimensioning, cover glass strength and fracture mechanics as well as review the fundamental principles of good glass handling and inspection.

  • Education
  • Europe

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Program Highlights
This course will include a Site Visit at the SCHOTT facilities on the 09 October 2019!

Overview

Glass vials, ampoules, syringes and cartridges are commonly used in packaging of parenteral pharmaceuticals. Good glass handling practices are essential to assuring glass-based container performance as intended in maintaining the safety and efficacy of the drug product.

The two-day course will offer insights into the science of glass and its inherent properties. It will review container design and dimensioning, cover glass strength and fracture mechanics as well as review the fundamental principles of good glass handling and inspection. The course will follow step-by-step the processes for packaging of parenterals in vials, ampoules, cartridges and syringes. Further insights into glass breakage including an overview of fracture analysis using fractography will be presented.

Prerequisites

  • Technical aptitude
  • Some familiarity with pharmaceutical fill/finish processes

Agenda

  • Day 1
  • Day 2
  • Wednesday, 09 October 2019

    9:00
    Welcome and Introduction Participants' Expectations


    Manufacture and Characteristics of Glass as Primary Packaging Material

    9:15
    Glass Science

    • Chemical structure
    • Physical properties
    • Different glass types in the pharmaceutical industry

    10:30
    Coffee Break

    11:00
    Glass Making

    • Glass Melting
    • Tubing Production
    • Container conversion
    • Molded containers

    12:00
    Lunch Break

    13:00
    Glass Strength and Fracture Mechanics

    • Trigger for glass breakage
    • Crack formation and propagation
    • Theory of Fractography

    14:30
    Site Visit SCHOTT Tubular Glass Manufacturing


    16:00
    Coffee Break

    Receiving Inspection of Glass Primary Packaging Material

    16:15
    Requirements from Pharmacopoeias (EP, JP, USP) and Incoming Inspection

    • Overview Pharmacopoeia
    • Testing Parameters
    • Testing Methods, Equipment, Tools
    • Defects and PDA Technical Report #43

    17:00
    How to Do in Practice

    • Sampling (AQL)
    • Sample size
    • Testing
    • Documentation
    • Supplier certification & test reduction

    17:30
    End of Day 1
  • Thursday, 10 October 2019

    9:00
    Recap of Learning Objectives Day 1


    Receiving Inspection of Glass Primary Packaging Material (cont.)

    09:30
    What to Consider, What are the Common Problems, How to Avoid Them

    • Indications for (later) glass breakage | Practical examples

    10:15
    Coffee Break

    10:45
    Coordination Process Packaging Manufacturer and Customer

    • Important parameters | Measured variables | Regulating variables | Control loop |Interaction with manufacturer | Effort reduction

    Machine Use of Glass Primary Packaging Material

    11:15
    Machine Runability of Glass Primary Packaging Material

    • Roughness of glass primary packaging material | Geometrics, tolerances | Quality of glass | Impact of machine speed

    11:45
    Lunch Break

    12:45
    Use of Glass Primary Packaging Material Along the Process Chain Considering different kind of containers, bulk and nested:

    • Washing machine | Depyrogenation tunnel | Filling machines | Stoppering | Rod insertion and labelling for syringes | Conveyor belts | Automated inspection | Packaging line

    13:30
    Case Study
    What to Consider, What are Common Problems, How to Avoid Them

    • Collision analysis
    • Basics of good glass handling
    • Technologies to avoid glass to glass contact

    14:15
    Coffee Break

    14:45
    Coordination Process Primary Packaging Material and Machine

    • Important parameters | Control loop | Synchronization

    15:30
    Q & A


    16:00
    Summary & End of Training Course

Trainers

Claudia Heinl
Claudia Heinl
SCHOTT AG
Florian Maurer
Florian Maurer
SCHOTT AG
Karl Siemoneit
Karl Siemoneit
Sanofi-Aventis
Klaus Ullherr
Klaus Ullherr
Robert Bosch Packaging

Additional Information

  • Learning Objectives

    Learning Objectives

    • Understands the nature of glass
    • Knows what glass breakage causes
    • Is aware of regulatory requirements and how to perform QC incoming inspection
    • Knows how to inspect glass containers for breakage-relevant defects
    • Is able to apply the knowledge to avoid glass breakage in the filling line
    • Is able to apply a structured way of evaluating in case of glass breakage
    • Is able to ‘read’ from the splinters and broken glass
  • Who Should Attend

    Who Should Attend

    • Packaging engineers
    • Quality personnel
    • Filling line technicians
    • Supervisors and engineering support
    • Those responding to failure complaints
    • Root cause investigators
  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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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.

IntercityHotel Mainz

Binger Str. 21
Mainz, Germany
Phone: +49 6131 58851-0

IntercityHotel Mainz
  • Accommodations

    Just 450 m away from the main train station is the IntercityHotel Mainz. Explore the old town district on foot, visit the many attractions such as the cathedral (approx. 17 minutes) and the Gutenberg Museum (approx. 19 minutes), or take a stroll along the Rhine promenade (around 18 minutes)!

    Despite its proximity to the train station, you can enjoy a peaceful night's sleep in any of our 194 soundproofed rooms and apartments. All rooms feature air conditioning, minibar, safe and a flatscreen TV with Sky Sports and Bundesliga channels!

    FreeCityTicket granting use of local public transport in Mainz and Wiesbaden at no charge.

    PDA Europe has reserved a limited number of rooms until the 10th September 2019.
    Single Room € 135 per night*
    Double Room Upon request

    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Frankfurt Airport - FRA
Airport Phone: +49 0180 6 3724636

By Car

38 min, 38 km by car. The InterCity Mainz is located at Binger Str. 21.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

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.

Special Dietary Requirements

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).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

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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Contact

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Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
[email protected]

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