Skip To The Main Content

Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

Aug 03, 2020
Bethesda, MD

  • Education
  • The Americas
Cancelled

Overview

This training course is designed to provide and evaluate recommendations specific to the operation of Blow-Fill-Seal (BFS) technology for the manufacture of sterile pharmaceuticals, e.g., injectable, ophthalmic, parenteral, and inhalation drugs and medical devices. Supplemental information to assist users with interpretation of international standards and regulatory guidance regarding BFS operations will also be provided.

Basic knowledge of aseptic fill/finish packaging, cGMP and regulatory requirements is desired.

For more options and/or related training courses, please visit the page(s) below.

PDA Parenteral Packaging Training Courses

Ask a Question

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Andrew W. Goll
Andrew W. Goll
Weiler Engineering, Inc.
Bio
Andrew W. Goll
Weiler Engineering, Inc.

Andrew Goll is a highly experienced Pharmaceutical manufacturing executive with more than 20 years of experience in Pharmaceutical manufacturing and Blow\Fill\Seal (BFS) Machine manufacturing and design.

Current role as Weiler Engineering, Inc’s. Chief Operating Officer and is a member of the site leadership team. Weiler Engineering produces between 10-15 ASEP-Tech BFS systems across 6 product lines, which are exported around the world. Andrew has worked for Weiler Engineering for 20 years and has held a range of roles for Weiler Engineering during these 20 years.
Martin Haerer
Martin Haerer
Rommelag CMO
Bio
Martin Haerer
Rommelag CMO

After receiving his Ph.D. in Pharmacy in 1990, Dr. Martin Haerer started at Holopack Verpackungstechnik GmbH as Assistant of the Production Manager. In the following years, he managed different projects in Production, Quality Control and Quality Assurance to improve the Quality System and Production.

In 2005, he was appointed Production Manager and Qualified Person, and since 2008, he has been Director for Pharmaceutical Affairs, responsible for all pharmaceutical and regulatory aspects in the company. Additionally, in 2001, he was elected Member of the Board of the BFS-IOA Association as Regulatory Officer.
Tim Kram
Tim Kram
Rommelag USA, Inc.
Bio
Tim Kram
Rommelag USA, Inc.

Mr. Kram is an Engineer and pharmaceutical business development professional, and is presently the General Manager for Rommelag Engineering’s US office. For the past 15 years he worked with companies to develop aseptic product fill/finish solutions using Blow/Fill/Seal technology. This work includes container development, clinical trials, regulatory filings, combination device development, primary drug packaging, machine sizing, validation/qualification, and commercial/contract manufacturing. For ten years, he has worked to introduce temperature sensitive biotech and vaccine products to BFS technology, and has received two foundation grants for the testing of injectable vaccines with BFS technology and CPAD device development. Mr. Kram regularly consults and gives presentations to BFS operators, industry groups and regulatory organizations. In the past, Mr. Kram has worked as a process engineer, filtration specialist, project manager and service engineer. He received a B.S. in Electrical Engineering from the Missouri University of Science and Technology in 1991.

Mr. Kram is an active member in the PDA, task force member Technical Report 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, task force member Technical Report 27 update: Pharmaceutical Package Integrity, ISPE member, AAPS member.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the recommended requirements necessary to utilize blow-fill-seal (BFS) fill/finish technology
    2. Assess if BFS technology can be applied to new or existing pharma products
    3. Describe the basic principles of BFS: cleanroom facility design, environmental monitoring, and aseptic processing
    4. Explain the process of evaluating product contact materials, extractable profiles and leachable risk
    5. Evaluate the aseptic risk of BFS in comparison to other advanced aseptic fill/finish operations: isolators and closed RABS systems
  • Who Should Attend

    This training course is intended for professionals who are involved in sterile drug manufacturing using blow-fill-seal processes.

    Departments
    Quality Assurance, Quality Control, Manufacturing, Packaging, Development, Technical Support

    Roles
    Analyst, Specialist, Engineer, Scientist, Supervisor, Manager

Got a Question? We have answers

Contact Us

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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By June 19, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979


Regular Registration
Registration Type Price After June 19, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979


* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

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

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

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

PDA Members Save Substantially