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Gerresheimer AG
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Syringe siliconization
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Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed,
siliconized, sterilized and packaged by the primary packaging
manufacturer. They can then be filled by the pharmaceutical companies
without any further processing. These days the majority of prefillable
syringes are made of glass and the trend looks set to continue. The
siliconization of the syringe barrel is an extremely important aspect of
the production of sterile, prefillable glass syringes because the
functional interaction of the glass barrel siliconization and the
plunger stopper siliconization is crucial to the efficiency of the
entire system. Both inadequate and excessive siliconization can cause
problems in this connection. The use of modern technology can achieve an
extremely uniform distribution of silicone oil in glass syringes with
reduced quantities of silicone oil. Another option for minimizing the
amount of free silicone oil in a syringe is the thermal fixation of the
silicone oil on the glass surface in a process called baked-on
siliconization. Plastic-based silicone oil-free or low-silicone oil
prefillable syringe systems are a relatively new development. Silicone
oil-free lubricant coatings for syringes are also currently in the
development phase.
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News and Press Releases |
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PCI Clinical Services Announces New Facility Dedicated to Clinical Trial Returns
Philadelphia, USA – October 15, 2018. Leading international pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced the completion of a dedicated Returns Management facility at its Clinical Services Center of Excellence at Bridgend, UK. PCI provides a full service Returns Management service for clients, providing visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study. Returning and reconciling Investigational Medicinal Product (IMP) on completion of a study is a critical part of a Clinical trial and can require complex reverse logistics. Trial outcomes can be impacted if Returns are not processed efficiently and precisely.
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White Papers |
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Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials
Perceptive Informatics
Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events |
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Biotech Showcase™ 2019
7-9 January 2019, Hilton San Francisco Union Square
Biotech
Showcase™ is an investor and networking conference devoted to
providing private and small- and mid-cap biotechnology companies an opportunity
to present to and meet with investors and biopharmaceutical executives during
the course of one of the largest annual healthcare conferences that attracts
investors and biopharmaceutical executives from around the world.
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