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Whitepaper: EU GMP Annex – sterile manufacturing
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
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Medical Devices
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On-demand webinar: Testing disinfectant agents for antimicrobial action on hard surfaces
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
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Novel blood cleansing device to enter first-in-human trial
The Garnet™ therapeutic product, which can capture more than 100 clinically relevant bacteria, fungi, parasites, toxins and viruses from the blood, will soon begin clinical testing.
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Drug-eluting contact lens shows potential in first-in-human study
The LLT-BMT1 drug releasing contact lens was safe, well tolerated and may have reduced the incidence of hyperaemia in an early glaucoma trial.
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Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 2)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
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Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 1)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
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On-demand webinar: Key elements of a sterility assurance program
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
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Application sheet: Mobile testing LabPODs
Readily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
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Whitepaper: Transmissible disease defense unit
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
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Connected drug delivery devices market to grow to $4bn by 2028
A new report reveals the COVID-19 pandemic, prevalence of chronic disease and increasing patient engagement will all drive adoption of connected drug delivery devices.
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Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
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Whitepaper: Why extractables and leachables matter
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
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Regulatory challenges and myths in pharmaceutical 3D printing
Although three-dimensional (3D) printing has been around for some time, many people still underestimate its capabilities. This article addresses the regulatory challenges faced by the pharmaceutical sector and aims to correct some of the most common myths surrounding the technology.
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Catalogue: Standard cleanroom POD
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
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Whitepaper: The necessity of E&L qualifications for lyophilised drug products
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
