Labels play an invaluable role on pharmaceutical packages. Pharmaceutical companies should only use labels that meet low-leachability and extraction requirements. Labels that are not migration safe, e.g. create leachable chemical compounds, may fail testing and result in significant launch delays or costly recalls. This white paper presents how pharmaceutical companies can ensure that the final label constructions achieve their business, regulatory and patient safety goals.
As more biologics and biosimilars come on to the global pharmaceutical market, they can and will present unique packaging and containment challenges. For materials that are sensitive to glass or that may require larger-dose volumes or custom configurations, cyclic olefin polymers may offer a solution. These novel materials for drug container closure systems can provide a needed alternative to traditional glass containment systems for advanced therapeutics.
Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.
For patients with chronic conditions, the use of injectable biologic therapies is on the rise. Biologics, while providing considerable therapeutic benefit, can also present several challenges for both drug manufacturers and patients. In particular, many biologics are highly viscous and others require large doses to be injected slowly over time. This can make it difficult to deliver a consistent dose every time, potentially impacting medication adherence.
With the ever-growing trend towards modularisation of clean rooms and laboratories; Teknomek have responded with a new range of PVC strip curtains, suitable for use in environments where maintaining clean airflow is critical. This new PVC curtain range includes specialist perforated and electrostatic discharge alternatives to the standard options of clear and polar (-25oC) versions.
Expenditures in post-approval (Phase IV) research are going up across the pharmaceutical, biotech and medical device industries. Given the resources you’ve committed to post-approval research, you may be wondering if you’re getting the greatest possible return on your investment.
Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!
UPM Raflatac has developed a range of pharmaceutical labelling products to support compliance with the Falsified Medicines Directive on packaging for prescription drugs and high-risk, over-the-counter medicines. Few solutions offer the same ease of adoption for meeting the February 2019 deadline.
This whitepaper is on clinical research in Spain, giving a general outline of the main characteristics of research in this country and an overview of the applicable regulations, along with the reasons why Spain is a good place to do research.
As an attractive target for cyber attacks, pharmaceutical companies need to understand cyber security, assess weak points and implement the appropriate security measures. This white paper describes some of the most effective industrial security tools pharmaceutical companies have at their disposal in the era of Industry 4.0.
Many of the world’s blockbuster drugs are now delivered via a prefilled syringe system or auto-injector. To ensure patient safety, pharmaceutical manufacturers need high-quality components that feature reduced particulates and ensure consistency of delivery while fitting the changing needs of higher-volume delivery systems.
Detecting Integrity Breaches in a range of Pharmaceutical Blister Package Types using Sepha VisionScan
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. Compared to bulk packaging, blister packs offer improved product integrity, tamper evidence and reduce the likelihood of misuse. Packs can be composed of either a thermoformed polymer or cold formed aluminium tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. These various stages can be completed separately or integrated into a single form, fill and seal process. There is a risk of microbial containment or degradation of the contents if any defects are present in the packaging. Such defects can take the form of rips or pinholes in the tray, or lid materials, faulty seals and channel leaks between pockets. More info >>
SMi is proud to announce
the return of their 6th annual Orphan Drugs event to Berlin on the 15th -16th
May 2017! The global orphan drug market totaled nearly $123 billion in 2014 and
will continue to grow to reach nearly $191 billion by 2019. More info >>