Nuclear Imaging Solutions
Every area in our radiopharmacies are designed to provide the highest standard of safety possible.
• PET Manufacturing, FDA Inspected cGMP quality systems. All PET products are manufactured using Current Good Manufacturing Practices (cGMP) under Federal Regulations 21 C.F.R. Part 212. Strict adherence to these rigorous quality standards ensures all PET products have the highest level of purity and consistancy for patient diagnostic imaging.
• USP 797 certified, ISO 7 clean rooms, and ISO 5 Filtration (SPECT Pharmacies)
These standards help protect patients and imaging staff from harm as a result of contaminated preparations. A brief outline of our quality controls are:
- Cleanroom and Equipment Certification
- Viable and Non-Viable Particulate Sampling
- Room Pressure Differentials
- Air Changes per Hour compliance
- HEPA Filter Tests
- Ventilation Assessments
- STET and Calibration
- Temperature Mapping of Refrigerators and Drug Storage
- High Temperature washing
Where many radiopharmacies use bleach, plastic inserts, or nothing at all, our ISO 7 Clean Rooms utilize high temperature washers and detergents to provide the cleanest shielded radiopharmaceutical enclosures (commonly known as "PIGS"). Studies show high temperature washing is the only cleaning method that ensures 100% decontamination of reusable PIGs.
• Low Dose Imaging Solutions
How can you lower radiation exposure to imaging technicians and patients, and still achieve excellent diagnostic image quality? PharmaLogic, through a partnership with UltraSPECT, offers the only FDA-approved image reconstruction system that can be retrofit into virtually all SPECT camera environments allowing you to cut your dosage in half! This retrofit solution avoids expensive investments in new camera technologies and is compliant with new ASNC radiation goals.
• Quality Control
PharmaLogic wants to provide you with the highest quality products in the nuclear medicine market. To ensure that we achieve this goal each lab tests 100% of our compounded radiopharmaceutical doses before we allow them to leave our pharmacies.