Comprehensive Solutions

Cyclomedical is known worldwide for outstanding expertise in all technical, investment, operation, and management aspects of PET nuclear medicine. As of April 2019 we have set up more than 50 PET biomarker production centers in 23 countries for our clients. In addition to facility planning, installation, and operating full production centers, we provide services and supplies useful to many cyclotron sites. All our sites are GMP compliant.

ANNUAL REQUALIFICATION PACKAGE FOR PET CYCLOTRON QC LABS

Performance Qualification (consistent with Pharmacopeia and Facility Standard Operating Procedures)

  • Gas chromatograph
  • High Performance Liquid Chromatograph
  • Ion Chromatograph
  • Pyrogen Test System
  • TSB Incubator, including temperature map
  • FTM Incubator, temperature map
  • Oven for depyrogenation, temperature map
  • Analytical Balance
  • Gamma Spectrometer
  • Dose Calibrator
  • Radio-Thin Layer Chromatograph
  • Check source strip for radiochemical purity (RTLC) *

Process Validation

  • Supervised media fill for personnel involved with aseptic processes
  • Production system bio-burden
  • Three lot qualification
  • Three lot product stability tests

Facility operation

  • Key Performance Indicators*
  • Equipment maintenance calendar & procedures

           *Cyclomedical proprietary

Maintain optimum operational efficiency and regulatory compliance for your laboratory instruments and processes with cost-effective services from Cyclomedical. 

Ask us for a quotation.

PET CYCLOTRON LABORATORY ANNUAL GMP AUDIT

Review:

  • Site Master File
  • Standard operating procedures
  • Production batch records
  • Quality control documentation
  • Personnel training records
  • Quality assurance trend analysis
  • Out of Specification incidents
  • CAPA documentation
  • Previous inspection reports and responses

Observe:

  • Manufacturing of all products
  • Quality control of all products
  • Raw material handling and control
  • Product batch approval and release
  • Product distribution

Provide Detailed Audit Report:

  • Report and recommendations keyed to cGMP regulations

Personnel training:

  • GMP site operation
  • CAPA training

PET BIOMARKER PRODUCTION SITE NEW PRODUCT INTRODUCTION

      Assistance in Introduction and Business Development of

        Innovative Nuclear Medicine Biomarkers

 (For example, [18F]FPSMA, [18F]FDOPA, [18F]FMISO, [13N]NH3, [68Ga]Dotatate)

Equipment evaluation and recommendation

  • Cyclotron
  • Synthesizers
  • Cyclotron targets
  • Generators
  • Quality control

Procedures

  • Standard Operating Procedures
  • Manufacturing
  • Quality control
  • Product stability
  • Raw materials control: Specifications, Suppliers

Services

  • Provide necessary equipment for each product
  • Supply consumables for production and testing
  • On-site startup for each product
  • Installation, Operational, Performance Qualification (IQOQPQ) for all new equipment
  • Production Validation for each product
  • New product stability testing

 

Personnel training

  • GMP site operation
  • Quality Control testing

Physician training

  • Physician instruction in utilization of novel products can be arranged.

CONSUMABLES:

We provide consumables to our new product clients worldwide:

  • O-18 Water
  • Synthesis kits
  • Endotoxin test cartridges
  • RTLC daily check sources for accuracy, constancy, and precision
  • …and much more.

How can we help you?

 

Provide the most effective diagnostic imaging agents with cost-effective services from Cyclomedical.  Ask us for a quotation.

 

 

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