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Technical & Engineering

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Radiopharmaceuticals production and distribution process is extremely expensive and complex. It entails handling of large quantities of radioactive substances and chemical processing. Ensuring cGMP compliance is a demanding task for manufacturer as it involves taking care of several aspects prior to, during and after production. These include the development of well qualified personnel, use of controlled materials and procedures, availability of qualified equipment, production of the products in designed clean areas, applying validated processes and analytical methods, full documentation of the process and release of the final product by a qualified person. Application of clean room requirements in radioisotope laboratories in general and hot cells in particular is technically demanding to be compatible with the requirements for both radiological and pharmaceutical safety.

PNS has already setup several GMP production facilities in different countries (EU and non-EU).

The Services include:

Lab design & building follow-up for research or commercial production

  • Review of the initial blue print and its compliance with GMP

  • Quality Assurance (QA): the very core of GMP for manufacturing of radiopharmaceutical

  • Lab qualification

  • Customized QA system for your operation
     

GMP engineering

  • Design your lab, qualify your equipment and validate your process

 

VMP (Validation Master Plan)

  • Drafting of your VMP required by EU Regulations

  • Control of different steps, final report

  • Drafting of the production’s SOPs

 

Process Optimization

  • Optimization of the whole production process from cyclotron to delivery
     

Customized Radiochemistry 

  • Provide reliable fully automated synthesizing solutions for many different 18F or 11C molecules (i.e. NaF, F-choline, FLT, F-MISO, MPPF, Fallypride, Faza, Bromofluoromethane, etc…)

 

Training

  • Provided by internationally renowned University Professors
    (see our Scientific Commitee)

 

Maintenance

  • Providing of high frequency maintenance for you production site in order to guarantee the improvement of your yields and keep them at theiroptimum 


For countries that cannot afford conventional production centers PNS

  • Provides and install the BG-75 Biomarker Generator

  • Assure a contractual follow-up with customers

  • On-line clinical and technical training sessions with our team        

  • Offer a maintenance program performed by our expert technicians

  • Give access to an "online assistance"

PNS & associates have a long track record in
developing radiochemistry modules for all sorts of molecules

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FDG

Chloride rubidium

[   F]FLORBETAPIR AV-45

18

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Fallypride

ACTINIUM-psma

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