White Papers

  1. Pharmaceutical Production Technology Transfers: Reaping Rewards, Reducing Risks

    There are a number of strategic advantages companies can achieve in pharmaceutical production by transferring production between sites. They can safeguard supply by producing at more than one site, and improve distribution by moving production closer to critical markets. They can also reduce program costs and risks by moving production to sites that are better qualified, can produce more economically, or are better positioned to meet the needs of regulators.

  2. Preventing Contamination During Sterile Powder Transfer

    Several techniques can be used to help ensure product sterility assurance during the transfer of pharmaceutical powders from one process stage to the next using an intermediate container (e.g., vessel or bag). One of these is split butterfly valve (SBV) technology. The ChargePoint AseptiSafe bio SBV traditionally uses hydrogen peroxide (H202) gas to bio-decontaminate and remove contamination on the two mating surfaces of the valve before the product is transferred. As shown below, the two halves of the valve create a sealed chamber by partially docking the two disc faces, allowing a decontamination to take place in a closed environment. This prevents further contamination from taking place after the decontamination process is finished, unlike the traditional sporicidal spray and wipe approach, which is generally carried out in an unsealed environment where further contamination could occur.

  3. QC Tests For Flow Properties Of Pharma Powders

    Understand why newer test methods are more effective than traditional methods.

  4. Medical Device Labeling — Regulations In The U.S., EU, And China

    While there are a certain amount of commonalities in regulations in each country, there are differences which necessitate care from global manufacturers when distributing products.

  5. Thermoplastic Material Selection For Injection Molding

    Every engineer who plans to quantitatively analyze a part, determine loads, stresses, strains, and environments has to make an optimal material decision based on their analysis. Every part should be engineered with the right materials, especially if life safety is involved, or reliability or efficacy is absolutely required. This white paper covers the many factors involved and how the environment and applications influence material selection in injection molding.

  6. Cross-Disciplinary Electronic Lab Notebooks (ELNs)

    ‘Cross-disciplinary’ Electronic Laboratory Notebooks (ELNs) are intended for scientists across research areas. More specialized ‘specific’ ELNs are intended for scientists working in a particular discipline.

  7. Beyond Item Level Serialization: Extending Traceability Schemes To Secondary And Tertiary Packaging

    Falsified and counterfeit medicines are a chronic problem for the pharmaceutical sector, with a third of all shipments in the worst affected parts of the world estimated to contain fake medicines. Highly portable and often extremely valuable, medicines continue to be a favorite with those determined to fake products or subvert the system for illegitimate gain. Faced with this continued global threat, legislatures around the world are responding by tightening the supply chain to stamp out illicit goods.

  8. The Hidden Challenges Of Pharmaceutical Serialization

    The true extent of the counterfeiting is unknown, since no global study has ever been carried out, but according to WHO estimates, up to 15% of all medicines are counterfeit.

  9. The EU Falsified Medicines Directive – Concerted Action To Secure The pharmaceutical supply Chain

    In recent years the production of, and trade in, falsified medicines – both research based and generic – has grown to become a global illegal business. At the borders of the EU alone over 30 million counterfeit medicines have been seized during the last five years, and the statistics regarding medicines supplied online are equally disturbing: according to the European Alliance for Safe Medicines, 62% of medicines purchased online are fake or substandard.

  10. Design Considerations For Overmolding And Insert Molding

    Overmolding is an injection molding process that allows an additional layer of resin to be added to an existing molded part to provide a combination of characteristics that no single material can provide. Material selection for overmolding can be complicated. Substrate and overmold resins can complement one another, but to be effective, they have to be compatible. Choices vary not just with the application of the overmolded part, but also with the method being used to produce it. Because processes and outcomes are more complex for overmolding than for single-shot injection molding, it is helpful to seek input from resin experts when selecting materials. This white paper provides a guide for chosing two-material molding and bonding options for plastics, elastomers, and metal inserts.