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WHITE PAPERS & CASE STUDIES

  • Takeda Upgrades Pharmaceutical Tablet Coaters With Minimum Downtime
    Takeda Upgrades Pharmaceutical Tablet Coaters With Minimum Downtime

    In order to keep up with fast developing technical standards, pharmaceutical manufacturers face the question whether investing in new equipment is the most profitable solution.

  • Achieving Results With Sterilization Training For Complex Production Processes
    Achieving Results With Sterilization Training For Complex Production Processes

    Training courses provided by the Bosch Packaging Academy support Alcon employees to ramp up expertise for SDR sterilizers.

  • How A Placebo Formulation Is Designed For An Oral Solid Dose Product
    How A Placebo Formulation Is Designed For An Oral Solid Dose Product

    To demonstrate the process by which a placebo formulation was designed for an oral solid dose product that would be dispensed to the patient as a fast-dissolve tablet.  The tablet is added to water and the resulting solution is dosed as a antibiotic mouthwash.   Placebo matching was required not only for the tablet but also for the solution which the patient took.

  • Improving Suspendibility Of A Water- Insoluble API For Oral Suspension
    Improving Suspendibility Of A Water- Insoluble API For Oral Suspension

    To improve the suspendibility of a water- insoluble active pharmaceutical ingredient (API) in a sorbitol- based reconstitutable powder for oral suspension formulation using two novel excipients Sentry™Polyox™WSR N80, NF (polyethylene oxide) and Avicel CL-611® NF (microcrystalline cellulose/carboxymethylcellulose sodium).

  • When The Chemistry Is Right: Controlling Inert Gases
    When The Chemistry Is Right: Controlling Inert Gases

    Proportional valve technology in process automation offers a great a deal of flexibility and produces high-quality control results.  A complete system supplied by Festo and installed in Boehringer Ingelheim's new technical centre demonstrates the performance that modern pneumatics can deliver.  The project was developed in close communication between the Festo team and automation experts from the pharmaceutical company, allowing it to move forward quickly.

  • 5 Ways To Streamline Biotech And Pharmaceutical Manufacturing Processes
    5 Ways To Streamline Biotech And Pharmaceutical Manufacturing Processes

    Today’s biotech and pharmaceutical production facilities must drive faster times to market and greater profitability for new products by boosting production yields and accelerating commercialization and scaling of capacity.

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PRODUCTS & SERVICES

Low Temperature Benchtop Bath: CharpyCool Low Temperature Benchtop Bath: CharpyCool

The new CharpyCool is a mechanically refrigerated bench top bath that eliminates the need for costly consumables such as liquid nitrogen or dry ice. Compact and completely self-contained, the CharpyCool offers up to 8 liters of working fluid volume enabling up to 91 Charpy impact test specimens to be accommodated at temperatures between -80°C and +30°C. A powerful variable speed magnetic stirrer and vortex breaker provide excellent temperature uniformity and stability enabling superior results. PID control enables the CharpyCool to sustain precise temperature control to within ± 0.1°C. The CharpyCool includes a digital temperature display, and an optional Charpy Rack is available which allows multiple-specimen loading and easy access to monitor your testing.

High Performance Tablet Deduster: KD7035 High Performance Tablet Deduster: KD7035

High performance tablet deduster for largest dedusting capacities equipped with the latest technology combined with a metal detector by Ceia or Lock. Tablets are dedusted and conveyed with our unique acceleration control and helix in the most sensitive way.

Vacuum Leak Detection Of Pharmaceutical Freeze Dried Products Vacuum Leak Detection Of Pharmaceutical Freeze Dried Products

Regulatory guidance (Eudralex 2008) explicitly states that containers closed under vacuum should be checked for the maintenance of that vacuum.  This guidance has led to the implementation of new types of inspection systems by the industry.  Because headspace analysis can rapidly and non-destructively detect changes in the headspace conditions, it is a leading candidate to use as a vacuum leak detection method for finished freeze dried product.

Lyophilization Chamber Moisture Mapping Lyophilization Chamber Moisture Mapping

Regulatory authorities require proof that lyophilization cycles have been developed logically and demonstrate uniformity. One measure of uniformity is the consistency of residual water content throughout a batch.

Pharmaceutical Headspace Oxygen Stability Studies Pharmaceutical Headspace Oxygen Stability Studies

Many of today's biopharmaceutical formulations may potentially suffer from oxidation to some degree. Large molecule formulations are relatively more delicate and may be prone to degrade in the presence of oxygen.  Besides a loss of efficacy and reduction in shelf life, exposure of such products to oxygen can result in product discoloration, changes in dissolution rate and profile, and even toxicity or other pharmacological properties associated with negative side effects. During the development of an oxygen-sensitive product, studies are performed that investigate the formulation’s interaction with oxygen. End-of-shelf-life stability studies verify that the product indeed retains efficacy under specified headspace oxygen levels. Such studies allow for the specification of appropriate initial headspace oxygen levels in the primary packaging.

Moisture Determination Of Lyophilized Vials Moisture Determination Of Lyophilized Vials

Moisture Determination
Residual product moisture content is a critical parameter when considering the stability and shelf life of lyophilized pharmaceutical product, sterile powders, or solid dosage product. Consequently, moisture analysis is performed in product and process development, as well as in commercial manufacturing to specify and control the maximum allowable moisture content. This is traditionally performed using Karl Fischer titration or thermo-gravimetric analysis (TGA) methods, which are destructive and labor & time intensive. Replacing these slow traditional methods with a rapid non-destructive method would streamline moisture analysis efforts and help improve the quality of finished product.

Tablet Deduster For Research Applications: Model E80-N Tablet Deduster For Research Applications: Model E80-N

Ideal for production of middle-sized charges and research applications.

Diverter For Tablets And Capsules: KV2010 Diverter For Tablets And Capsules: KV2010

Manual 2-way diverter used for continuous filling of containers with tablets or capsules.

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