Enam faktor untuk memenuhi regulasi dalam farmasi dengan sistem komputerisasi

Bagaimana menenuhi regulasi 21 CFR Part 11

Manfaatkan panduan gratis kami dengan mempelajari penentuan kadar nitrogen yang sesuai dalam senyawa farmasi berdasarkan regulasi 21 CFR Part 11. Pelajari lebih lanjut tentang regulasi dan cara memenuhinya, sebagai berikut :

  • Pemeliharaan catatan data elektronik dengan Audit-Trail
  • Persyaratan untuk tanda tangan elektronik
  • Struktur dari user level management dan otorisasi level
  • Fitur keamanan untuk login

Plus, dapatkan akses ke kesempatan waktu terbatas untuk mengumpulkan bahan habis pakai gratis.

 
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Discover the KjelMaster K-375 Pharma Package features

The Pharma Package makes Kjeldahl analysis fully applicable for the Pharma industry, all new features are aligned with the 21 CFR Part 11 requirements:

IQ/OQ and training
Data records
Data traceability
Electronic signature
Security
User Administration
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Kjeldahl applications in the Pharma Industry

The Kjeldahl analysis is a very robust, primary reference method to measure nitrogen contents in various matrices. Different application fields can be found, where the total nitrogen content plays an important role for analyte quantification:

APIs:
Nutraceuticals
Ointments
Biopharmaceuticals
Blood plasma products:
Biomaterials
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“The BUCHI Kjeldahl equipment is a unique combination of sample digester, scrubber, distiller and titrator. All work in conjunction and provide integrated reproducible data. It is a user friendly and time saving equipment. Its advanced automation reduces labor cost and is very much useful in pharmaceutical industry.”

Ph.D. Venkat Reddy Guduru

Bactolac Pharmaceutical, Inc.

KjelMaster K-375 - the instrument for the Pharma industry

Flexible operation

  • Comply with the official Kjeldahl norms (AOAC, EPA, USP, ISO, EC and DIN) thanks to the choice of colorimetric, potentiometric or back titration setup
  • Automatic data exchange with peripherals (balance, bar code reader, printer, LIMS and more)

Use different and secured access levels of authorization, thorough reporting and tracked data manipulation.

Easy to use

  • Control and input data via the large graphical color touch screen (8.4")
  • Attach via LAN to the network and make use of traceable data management
  • Ease your daily work with BUCHI’s Kjeldahl Apps (Kjeldahl Optimizer and Kjeldahl Tablet Configurator)

Avoid downtimes with preventative maintenance and tailored service packages.

Maximized productivity

  • Shortest time-to-result due to well synchronized process steps
  • Upgrade onsite for highest sample loads by connecting the KjelSampler to the KjelMaster
  • Fully automated workflow for high sample loads synchronized with digestion process

Quick determinations of priority samples while a running sequence using “Express Racks” with KjelSampler.