INSIGHTS ON PHARMACEUTICAL INSPECTION
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Innovative Leak Testing Of Pharmaceutical Blister Packages
Learn how to obtain highly sensitive, quantitative measurements in real-time without specific tracer gases.
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Choosing The Right Primary Container And Troubleshooting Issues
Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development – and quickly uncover causes of failures.
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Effects Of X-Ray Inspection On Pharmaceutical Products
Some manufacturers still have reservations about adopting x-ray inspection as a safe method of product inspection. Explore the potential effects of x-ray inspection on pharmaceutical products and more.
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Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing
Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.
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How To Select A Tracer Gas Leak Detection Method And Technology4/28/2022
Here, we outline the best practice for leak testing of components in a broad range of applications and provide practical advice regarding the use of leak testing equipment.
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USP <922> Water Activity Has Opened A Door For OSD Manufacturers6/20/2022
Learn more about USP <922> Water Activity and why using Karl-Fischer titration to measure total water content is no longer adequate to fully understand the stability of oral solid dosage products.
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USP <922> Water Activity Testing For Oral Solid Dose Pharmaceuticals8/26/2022
Gain insight into the technical and regulatory justification for adding water activity measurements into pharmaceutical stability protocols.
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Bombing - Leak Test Of Hermetically Sealed Objects4/28/2022
Learn in detail about the best practice of leak testing of hermetically sealed devices in microelectronics, sensor technology, and other industries.
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High Voltage Leak Detection For Parenteral Drug Container Closure Integrity2/25/2023
Medical and pharmaceutical products are often packaged in fluid-filled containers. Learn about container closure integrity testing using high voltage leak detection (HVLD), how HVLD technology works, and more.
PHARMACEUTICAL INSPECTION SOLUTIONS
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Our USP <1207> and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV bags, pouches, or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100 % testing (also in inline machines).
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Our patented O.E.S. (Optical Emission Spectroscopy) method does not require any specific tracer gas. Instead, the gas mixture present in the container headspace of the primary packaging is used to perform high sensitivity tests with high throughput. A multi-gas sensor is used to independently track the different gases (i.e. argon, nitrogen, CO2, humidity,…) escaping from a leaky container exposed to vacuum. Our method is non-destructive, deterministic, easy to use and to set up, faster and has higher sensitivity than other conventional methods. O.E.S. is able to detect down to 0.2µm defect size on glass containers which corresponds to the sterility barrier defined as the MALL (Maximum Allowable Leak Limit) in the USP<1207> guidelines.
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Manipulator machines can process a wide range of different containers such as vials, cartridges, and prefilled syringes, either bulk or nested, in order to meet the current pharmaceutical industry requirements and to address the end users' needs. They are designed to ensure the integrity of high-value products such as biotechnology, nuclear, cytotoxic, and more, or to treat different containers with a single machine thanks to the use of manipulator robots. These machines can be customized by joining our professional skills in filling and inspection applications and users' requirements.
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The A&V automatic inspection machines are designed for particles and cosmetic inspection of ampoules, vials, and cartridges.
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Used Brevetti vial inspection unit, model A1, speeds up to 360 pcs/hour, currently set up for 53.5 mm diameter 100 mL vails, 8mm - 95 mm diameter x up to 240 mm high vial size range, with integrated robotic arm, (4) inspection units, with vial feed infeed and acceptable exit tables, dual reject stations, with HMI panel, serial# BM242, built 2016.