Aseptic Filling and Packaging by mikesanye

VIEWS: 439 PAGES: 6

									 FDA Warning Letter Excerpt: “ . . . no validation of environment for aseptic filling machines…”




 ASEPTIC FILLING
   & PACKAGING
        REGISTER by                                  for Sterile Drugs and Devices
       August 29th and
           receive
       a $300 discount                                 Methods and Technologies for Sterile Drugs
                                                                 and Devices from Industry Leaders
                                                       October 2-3, 2008 • Tremont Marriott • Boston, MA

                          LEARN FROM LEADING INDUSTRY EXPERTS!


             CATALENT and
           MEDICAL HOUSE PLC.                                     TRI-INTERSECT SOLUTIONS
        Aseptic Packaging of Parenterals            USP’s Perspectives and Guidelines
              that are Drug-device                            on Packaging
                                                                                    Former USP
                  Combinations           9 IN-DEPTH                                   Director
                                                     CASE STUDIES

          BD MEDICAL-
    PHARMACEUTICAL SYSTEMS                                     PIERRE FABRE LABORATORIES
              and                                                        Aseptic Potent Fill/Finish
    SARTORIUS STEDIM BIOTECH                                                 Using Isolators
   Designing a System for Aseptic Transfer
     of Pre-fillable Syringe Components



                 SKAN US INC.                                              METALL+PLASTIC
        Syringe Filling in Isolators with                        Lessons Learned from Isolated Filling
         e-Beam Tub Decontamination                                    and Lyophilization Line
                                                 LISTEN AND LEARN
                                              ABOUT LATEST TRENDS AND
                                                     DIRECTIONS

                      BIOQUELL                                       CINTAS CORPORATION
                                                                     Validation of a Cleanroom
  Advantages Utilizing Bio-decontamination
                                                                   Gowning System and Protocol for
    HPV Technology for Aseptic Facilities
                                                                        Aseptic Applications


                                                                                             …..AND MANY MORE
REGISTER NOW! Call 813-655-7788 or email: registration@sweinc.biz or go to: www.sweinc.biz

                                  Organized By: SWE Enterprises • P.O. Box 23202 • Tampa, Florida 33623
                                 Telephone: 813-655-7788 • Fax: 413-480-9953 • Website: www.sweinc.biz          1
                   FDA Warning Letter Excerpt: “…failed to establish an adequate system for cleaning and disinfecting
                                                 the room and equipment to produce aseptic conditions…”



                     DAY ONE                                        advances and capabilities for these transfers. Finally, a case study
             THURSDAY, OCTOBER 2, 2008                              of a complete component transfer system will be reviewed
                                                                    featuring the validation of a system designed jointly by a pre-
7:30    REGISTRATION AND BREAKFAST                                  fillable syringe system provider and aseptic transfer supplier.

8:45     CHAIRPERSON’S WELCOME AND                                  The objectives are for the attendee to become current in their
         OPENING REMARKS                                            knowledge of transfer systems, allowing them to make the best
                                                                    decision for a particular application.
CASE STUDY
                                                                    11:00 MID-MORNING BREAK
        IN DEPTH SESSION FROM FORMER
    DIRECTOR, COMPLEX ACTIVITIES DIVISION,                          CASE STUDY                  CO-PRESENTATION
              US PHARMACOPEIA
                                                                    11:15 ASEPTIC PACKAGING OF PARENTERALS
9:00     USP’S PERSPECTIVES AND GUIDELINES ON                             THAT ARE DRUG-DEVICE COMBINATION
         PACKAGING                                                        Matthew Pino, Director of Business Development
         Roger Dabbah PhD, MBA, Principle Consultant                      for Sterile Technologies
         TRI-INTERSECT SOLUTIONS                                          David Urquhart, Managing Director
                                                                          CATALENT PHARMA SOLUTIONS
The US Pharmacopeia organization is described as background               MEDICAL HOUSE PLC.
to the review of the various chapters devoted to packaging.
USP describes in details the quality requirements for containers    Understanding the challenges and decision making process
(glass and plastic) and the various elastomeric closures, in        regarding the development, licensing and outsourcing of pre-
terms of their chemical and biological requirements. We will        filled syringes and drug/device combination products (i.e.
describe the various biocompatibility tests that can be used, in-   disposable autoinjectors and safety devices).
vivo and in vitro. Guidelines for Packaging unit-of-use will also
be discussed. In the aseptic processing area we will discuss the    The most prominent trend in the pharmaceutical industry in the
microbiological evaluation of cleanrooms and other controlled       past few years has been the change in the pipeline portfolio
environments, as well as the validation of isolators"               from small molecule to large molecule compounds. These
                                                                    compounds (monoclonal antibodies; vaccines and therapeutic
 • USP requirements are enforceable by the FDA in their             proteins etc) have been to a large extent discovered by small/
   compliance inspections and in the evaluation of new              virtual biotech companies.
   products applications
                                                                    These biotechnology companies typically lack the
 • In aseptic processing the microbiological quality of the         manufacturing infrastructure/operations to support their needs
   manufacturing environment affects the microbiological            for their expanding portfolio and are looking to various
   quality of the finished products                                 outsourcing networks.

CASE STUDY                  CO-PRESENTATION                         Most of these molecules are in an injectable format based on
                                                                    their size. Pre filled syringes are the most preferred option of
10:00 DESIGNING A SYSTEM FOR ASEPTIC                                delivery of vaccines; biologics based on several reasons. In
      TRANSFER OF PRE-FILLABLE SYRINGE                              addition, the recent changes in the health care reimbursements
      COMPONENTS                                                    etc are forcing companies to find ways by which patients rely
      Patrick Begley, Manager, Technical Services                   more on self injectable drugs/ in home medication vs going to a
                                                                    hospital.This has resulted in driving the outsourcing market for
      Gene Fuchs, Field Marketing Manager, Aseptic
                                                                    biologics in a pre-filled syringe and drug/device injectable
      Transfer and Drug Delivery                                    combination products
      BD MEDICAL- PHARMACEUTICAL SYSTEMS
      SARTORIUS STEDIM BIOTECH                                      Based on these changing trends, the (CMO’s) contract
                                                                    manufacturing organizations are revamping themselves to come up
This presentation examines three key components to optimal          with business models and value propositions that are based on the
system design for component transfer into a pharmaceutical          changing needs and the latest trends in the health care industry.
barrier isolation system. Included will be a review of available
transfer systems currently in use and a discussion of design


    REGISTER NOW! Call 813-655-7788 or email: registration@sweinc.biz or go to: www.sweinc.biz                                             2
This presentation will focus on understanding the challenges         presented with support of photos. The presentation will also
and key drivers in the development, licensing and outsourcing        include the new concept of washing in place of isolators.
of pre-filled syringes and drug/device combination products
(i.e. disposable autoinjectors and safety devices
                                                                     3:15     AFTERNOON BREAK - 7th INNING STRETCH
12:15 LUNCHEON
                                                                        CASE STUDY INCLUDING DATA FROM MAJOR
                                                                              PHARMACEUTICAL COMPANIES
                EXTENSIVE COVERAGE OF
                ASEPTIC LYOPHILIZATION
                                                                     3:30     SYRINGE FILLING IN ISOLATORS WITH
                                                                              E-BEAM TUB DECONTAMINATION
CASE STUDY
                                                                              Jim Spolyar, Technical Director
                                                                              SKAN US INC.
1:15     LESSONS LEARNED FROM ISOLATED
         FILLING AND LYOPHILIZATION LINE
                                                                     This presentation will highlight recent experiences from “state-
         Jim Vogel, Technical Consultant
                                                                     of-the-art” aseptic processing lines that have been installed for
         METALL+PLASTIC                                              pharmaceutical syringe filling around the world, including sites
                                                                     at GlaxoSmithKline, Janssen (Belgium), Sanofi-Aventis
This case study for the design, construction, startup, and           (France),and Novartis (Switzerland).
validation for a major aseptic filling and lyophilization facility
will present the challenges, critical success factors and outcome
of a major capacity expansion for a leading injectibles               • Review the isolator and E-Beam design features and latest
manufacturing facility.                                                 developments

The case study will address facility design requirements and          • Review customer experiences in choosing isolators over a
process equipment requirements and will present the project             traditional clean room or Restricted Access Barrier System
implementation methodology that resulted in a 14 month time             (RABS)
line from beginning of site work through all construction and
equipment installation complete.                                      • Review the project schedule and any challenges that were
                                                                        encountered, while getting each system installed, validated
The attendees will take home an understanding of the key steps          and in operation.
in designing a sterile manufacturing facility, selection of
process equipment and the key factors in rapid project
execution.                                                           4:15     INTERACTIVE PANEL DISCUSSION
                                                                              INCLUDING ALL DAY ONE SPEAKERS
CASE STUDY
                                                                      • Current trends in aseptic drugs and sterile devices
2:15     LESSONS FROM A HIGH POTENT ASEPTIC
                                                                      • Experiences from aseptic packaging of devices
         FILL FINISH LYOPHILIZATION FACILITY
         Paul Martin, Contract Manufacturing                          • Aseptic fill challenges
         PIERRE FABRE LABORATORIES                                    • Questions and answers

Pierre Fabre has 15 years of know how and expertise in aseptic
filling under isolator technology, for high potent drug, with US     5:00      END OF DAY ONE
FDA approval. My presentation is oriented on a review of the
three different generations of filling lines under isolators we
currently have used for the manufacture of cytotoxics since the
1990’s. The presentation will then show a more detailed picture
of the new generation of aseptic fill finished lyo facility for
high potent drugs, we have built and qualified this year. The
new facility operates with 100% of the process under new
isolator technology, and in compliance with new EU Anti
Explosion rules.

Details on specifications of equipment, technical approach and
the specific characteristics of the suite, such as pressure
regulation and temperature, impact and explosion-proof, will be



    REGISTER NOW! Call 813-655-7788 or email: registration@sweinc.biz or go to: www.sweinc.biz                                           3
                           DAY TWO
                                                                      innovations make Blow/Fill/Seal an advantaged technology for
                FRIDAY, OCTOBER 3, 2008                               the delivery of injectable products.

7:00    BREAKFAST                                                     Blow/Fill/Seal is an advanced aseptic manufacturing process
                                                                      where a plastic container is formed, filled with liquid product,
8:15    CHAIRPERSON’S OPENING REMARKS                                 and sealed – all within an enclosed process that requires little
                                                                      human intervention. The technology is well established for the
CASE STUDY                                                            manufacture of sterile liquid pharmaceutical products, and has
                                                                      been the technology of choice for unit-dose nebulizer solutions
8:30     ISOLATED TUB SYRINGE FILLING LINE                            and ophthalmic products for many years. The same advantages
         UTILIZING E-BEAM TECHNOLOGY                                  that Blow/Fill/Seal brings to these products (quality/sterility
         Jim Vogel, Technical Consultant                              assurance, processing efficiencies, flexibility in container
                                                                      design), combined with recent process and design innovations,
         METALL+PLASTIC
                                                                      make it a viable delivery option for injectable products vs.
                                                                      traditional glass or plastic vials.
This case study will present the rationale for design, equipment
selection, and line validation for a state of the art sterile pre-
                                                                      This presentation will provide an overview of the
filled syringe filling line. The presentation will present a
                                                                      Blow/Fill/Seal manufacturing technology, discuss its
technology overview of e-Beam technology which was used to
                                                                      advantages for sterile pharmaceuticals, and highlight a new
decontaminate the surface of the syringe tubs prior to their
                                                                      Blow/Fill/Seal offering for injectables.
entry into the isolated filling line.

The case study will include critical success factors for              12:00 LUNCHEON
achieving a positive project outcome.
                                                                            CLEANROOMS AND DECONTAMINATION
This presentation will provide an understanding of the
execution of a world class state of the art pre-filled syringe line   1:15     VALIDATION OF A CLEANROOM
utilizing e-Beam technology.                                                   GOWNING SYSTEM AND PROTOCOL FOR
                                                                               ASEPTIC APPLICATIONS
CASE STUDY
                                                                               Jan Eudy, Corporate Quality Assurance Manager
9:30     ASEPTIC LINE FOR SMALL BATCH SIZES                                    CINTAS CORPORATION
         John Erdner, Director, Liquid Division
                                                                      Validating a cleanroom apparel system is essential for aseptic
         IMA NORTH AMERICA
                                                                      operations. During the IQ (Installation Qualification), OQ
This is a case study presentation of an aseptic line designed         (Operational Qualification) and PQ (Performance Qualification)
specifically for the flexibility and quick changeover that is         phases of validation, consideration of fabric, garment design,
required with small batch size applications. Sometimes                and suppliers must be evaluated.
production capacity is not related to how fast your line runs but
rather how quickly you can end a batch and start a new one.           When selecting a garment system for aseptic cleanroom
                                                                      applications one must evaluate several parameters that comprise
Flexibility is essential when planning to run many different          the garment system. What are the mechanisms of action? Can
products on the same line. A variety of filling systems can be        results be quantified?
quickly changed from batch to batch along with pressure
cascades The modular design permits the flexibility to start with     The function of the garment system. Does the garment system
the basics and add modules in the future to automate washing,         contain particles and microorganisms? Parameters which should
depyrogenation, auto or semi automatic Lyo loading, capping,          be evaluated and quantified are:
external vial washing, cap coding, and tray off of vials.
                                                                       •   non-particulating
                                                                       •   small nominal pore size
10:30 MID-MORNING BREAK                                                •   liquid repellency
                                                                       •   antimicrobial
10:45 DELIVERY OF PARENTERAL DRUGS USING                               •   static dissipative
      BLOW/FILL/SEAL TECHNOLOGY                                        •   gamma compatible
      Michael A. Riley, Vice President, Business Development           •   suitable design
      Dan Osterby, Director of New Product Development
      CATALENT PHARMA SOLUTIONS                                       The comfort of the garment system. Is the garment system
                                                                      wearable in aseptic cleanroom applications? Parameters which
We will review the advantages of Blow/Fill/Seal technology for        should be evaluated and quantified are:
the manufacture of sterile pharmaceuticals, and how recent

   REGISTER NOW! Call 813-655-7788 or email: registration@sweinc.biz or go to: www.sweinc.biz                                            4
 •   moisture vapor transmission rate
 •   weight of fabric                                                 CASE STUDY
 •   hypoallergenic
 •   system design                                                    2:15      ADVANTAGES UTILIZING
                                                                                BIO-DECONTAMINATION HYDROGEN
What is the cost to the customer? Is the garment system
                                                                                PEROXIDE VAPOR (HPV) TECHNOLOGY
affordable? Parameters which should be evaluated are:
                                                                                FOR ASEPTIC FACILITIES
 • multiple daily changes                                                       Martin Orlowski, Regional Sales Manager
 • calculated cost per use                                                      BIOQUELL INC.

There are several parameters to consider when evaluating              The presentation will touch on general background of the
cleanroom fabric options such as:                                     technology, technical developments, material compatibility,
                                                                      efficacy, and real-life case studies within the various research
 • Non-woven (spunbonded polyolefin - Tyvek®)                         fields.
 • Membrane laminates (PTFE – PolyTetraFlouroEthylene)                Basic background on HPV, advantages and disadvantages of
 • Woven                                                              the technology

There are several parameters to consider when evaluating              Different uses for the technology
cleanroom garment design options, however the industry
guidelines of the IEST-RP-CC003.3, “Garment System                    •   Rooms
Consideration for Cleanrooms and Other Controlled                     •   Rack washers/sterilizers
Environments” should be adopted. Some parameters evaluated are:       •   Decon chambers
                                                                      •   Incubators
• Coverall components                                                 •   Biological safety cabinets
• Headwear styles
• Footwear styles                                                     Information on Hydrogen Peroxide Vapor (HPV)

Validation Protocol                                                   •   Efficacy of HPV
                                                                      •   Material compatibility of HPV
The prime objective of validating a cleanroom garment system          •   Three basic stages for HPV decontamination
is to prove that the garmenting system will function to contain       •   Killing mechanism of HPV
particles and microorganisms during use. The purpose of the IQ
– Installation Qualification is to verify that the product received   Room/Facility Decontamination using HPV
is as specified and sterile. This section of the validation should
include an audit of the supplier and verification of quantifiable     • Three different techniques to decontaminate rooms
data. The purpose of the OQ – Operational Qualification is to         • Pre-commissioning/Outbreak decontamination of facilities
verify that the garment system can be donned and worn into the
sterile environment and remain sterile. This section of the           Case Studies using HPV
validation should include garmenting protocols, personnel
training, execution of standard operation procedures and
verification of quantifiable data. The purpose of the PQ -            3:30 CLOSE OF CONFERENCE
Performance Qualification is to prove that the garmenting
system will function to contain particles and microorganisms
during use. This section should include an in-use trial and
verification of accrued quantifiable data.

In summary, when a garment system is validated, all critical
parameters are evaluated and the accumulated data supports the
purpose as stated in the validation protocol.




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                                                            ASEPTIC FILL & PACKAGING
                                                                    for Sterile Drugs and Devices
    SWE ENTERPRISES, Inc.
    Pharmaceutical Conference Division                                   October 2-3, 2008
    PO Box 23202                                                   Tremont Marriott • Boston, MA
    Tampa, FL 33623




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