PHARMACEUTICAL INSPECTION SOLUTIONS

• Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements

  As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.

• Helium Leak Detection For Combination Drug Products

  There have been many advances over the past decade in terms of drug product delivery methods. As a result, key developments like unique cartridge based delivery systems have become common. It is well documented that Helium mass spectrometry is most suited for non-porous packaging such as vials and syringes. The same methodology can also be applicable to cartridge based delivery systems. In most cases the key to success is the development of a text fixture device designed and manufactured to the specific cartridge system being testing. These custom fixtures for helium leak detection can be designed to isolate specific areas of interest in the cartridge system.

• Aerosol Checkweigher For Pharmaceutical Applications

  Anritsu's aerosol checkweigher is engineered for accurate weighing of aerosol cans in pharmaceutical applications. It features a star wheel mechanism that feeds cans onto the weigh table at a constant speed and with uniform spacing. This design, combined with a high precision electromagnetic weigh cell, ensures a throughput of up to 150 cans per minute, with a weighing accuracy of ± 10 mg. The checkweigher has a compact footprint, integrating within the same frame a reject mechanism and confirmation function, ensuring that only correctly weighed products pass through. Underweight and overweight cans are automatically directed into two separate bins located beneath the weigh table. The system is compliant with federal regulation 21 CFR Part 11 for the integrity of electronic records and signatures, with features such as password authentication, audit trail of operation data, and encryption/decryption of exported data.

• X-Ray Inspection: X52

  A premium dual energy x-ray inspection system offering outstanding detection of hard-to-find, low density contaminants, in a variety of applications. Available in standard and custom configurations.

• Timely And Highly Reliable In-Air Pathogen Surveillance

  Discover a pathogen surveillance solution that delivers timely and highly reliable insight into in-air pathogen presence, so you can monitor and improve your facility safety protocols.

• Next-Generation Industrial Metal Detection System
• Helium Leak Detection For Bottles
• Force Decay Pharmaceutical Leak Testing System
• Advanced Product Inspection Technologies For Pharma And Biopharma