Exhibitors List Frankfurt Conference 2011

DEC Deutschland GmbH

DEC is a global provider of powder handling and containment solutions to the process industry.

GLATT Ingenieurtechnik GmbH

Technology, engineering, equipment and GMP compliance for the pharmaceutical, biotechnology and medical devices industries.

NNE Pharmaplan GmbH

Engineering, consulting and GMP compliance in the complex field of pharma and biotech.

Steriflow Valve

Steriflow Valve is the leading source for high performance, high quality sanitary valves.

Bayer Technology Services GmbH

Bayer Technology Services GmbH offers fully-integrated solutions along the life cycle of chemical/pharmaceutical plants?

HECHT Technologie GmbH

HECHT offers solutions to make the use of solids safer, easier and more efficient.

DRIAM Anlagenbau GmbH

Automatic film and suspension coating installations for 5-3000kg batches; continuous intermittent coating (mini-batches).

Zotefoams Plc.

T-Tubes™ High Performance Cleanroom Insulation System
BioShell High Performance Frozen bag Product Protection System

Vaisala GmbH

Messtechnik und Monitoring-Lösungen von Vaisala: Messwertgeber für Feuchte, Temperatur, CO2, Luftdruck, Datenlogger, Monitoring- und Alarmsystems, Service.

GE Measurement & Control Solutions

Visit the GE booth to see Kaye wired and wireless thermal validation systems; wireless process validation and monitoring, centralised facility monitoring, alarming and reporting systems. New Kaye LabWatch™ Pro! With flexible and scalable architecture, the system can be customised to meet specific facility needs while staying compliant.

Flowserve Gestra AG

Valves for pure and sterile steam systems, steam traps, non return valve, pure steam generator.

zeta Biopharma GmbH

Upstream processing, Downstream processing, Preparation and formulation systems, CIP/SIP- and media systems, Process equipment, Sterile-plant installation, Automation systems, Agitators and mixing technology, Freeze and thaw systems.

ICE A/S

IT solutions to improve manufacturing performance: Electronic Batch Recording, Electronic log books, OEE, ICE Lean.

Rescop BV

RC-ECMS; Rescop paperless software solution for all validation and compliance activities throughout the TLC for every given computerised system.

SCHOTT forma vitrum AG

SCHOTT Pharmaceutical Systems is one of the world's leading suppliers of glass tubing and primary packaging for the pharmaceutical industry.

Rohrback Cosasco Systems Inc.

Online/real-time rouge monitoring systems: determining rouge rates and rouge accumulation in pharmaceutical water systems.

Kneat Solutions

Kneat streamlines and automates the capture, management and presentation of your important information in a secure collaborative environment.

Camfil Farr APC

We supply safe-change, contained ATEX compliant dust collectors and long life, low energy (TCO) cartridge air filters.

Brevetti Angela SRL

Machines for aseptic packaging of parenteral liquids and for pre filled syringes with BFS technology.

Getinge Infection Control AB

Provides complete solutions for contamination prevention and infection control, sterilizers, washers, utility systems, isolators, loading equipment, service & support, education etc.

STEELCO SPA

STEELCO is a company established in 1945 with the aim to become a dynamic and recognized partner in the production of washing equipments.

Foster Wheeler Italiana

Engineering, procurement, project management and Qualification Services in Pharmaceutical, Biotechnology and Healthcare Sectors.

Hach Lange GmbH

HACH LANGE - leading brands for LifeScience applications:

  • ANATEL TOC-Analysis
  • ORBISPHERE Ozone/Oxygen Analysis
  • HIAC LiquidParticleCounters
  • MetOne AirborneParticleCounters

Lighthouse Instruments

LIGHTHOUSE is the leading global provider of laser-based, non-destructive head space inspection systems. The company has implemented a range of automated machines and manual bench top systems that help monitor sterile processes and ensure the sterility and stability of finished pharmaceutical products.

   
  Vendor Solution Presentations

ISPE and Lighthouse invite you to attend their Vendor Solution Presentation.

When: Monday, 11 April 2011
Time: 13h00 - 13h30
Where: In the Vendor Area

Headspace Systems for 100% Container Closure Inspection 
of Freeze Dried Vials

Container closure integrity plays an important role in maintaining the sterility and stability of lyophilized products.  Concerns over patient safety, customer complaints, and the cost of investigations and product recalls have resulted in revised regulatory guidance (e.g. Annex 1 revisions to the European Guidelines for the Manufacture of Sterile Products).  There is a corresponding drive in the industry to implement inspection systems to help ensure the seal integrity of finished product vials.

 

Several industry case studies are presented in this Vendor Session.  All of these case studies involved 100% headspace inspection of commercial batches of freeze dried product vials.  In each case, the inspection activity identified raised stopper issues which resulted in the loss of container closure integrity for a subset of samples in the batch.  Not only were vials identified that had lost closure but insight was also gained into packaging and process issues that may have been the root cause of the raised stoppers.  

 

Finally, concrete approaches that a freeze dried manufacturer can take to manage the risk of raised stoppers in the process and subsequent loss of container closure integrity in the finished freeze dried product vials are described.

 

ISPE and SCHOTT forma vitrum ag invite you to attend their Vendor Solution Presentation.

When: Tuesday, 12 April 2011
Time: 13h00 - 13h30
Where: In the Vendor Area

SCHOTT is supporting the efforts of pharmaceutical companies to improve production processes and the product quality of drugs. We do this with primary packaging containers in glass and COC (Polymer) setting standards on the market. Our focus lies on the maintenance of safety and stability of injectabilia by offering e.g. high performance vials like SCHOTT TopLine Vials that are manufactured and inspected in accordance with customer requirements or special solutions like SCHOTT Type I plus and SCHOTT TopLyo for applications associated with very sensitive drugs.