SCA Pharma features state-of-the-art in-house laboratories to support the entire quality organization. Our labs include:
The Chemistry Laboratory at our Windsor facility is responsible for developing and implementing robust analytical test methods that meet ICH validation criteria and that are stability-indicating. The laboratory conducts analytical release testing for each batch of finished product and full stability studies to support the product Beyond Use Date (BUD).
Our Chemistry Laboratory is equipped with:
- High-Pressure Liquid Chromatography (HPLC)
- Ultra High Pressure Liquid Chromatography (UPLC)
- Liquid particle counters
- Thermo and Caron stability chambers and refrigerators
- Karl Fischer Titration
- pH meter
- Atomic Absorption
Our Microbiology laboratories are equipped with state-of-the-art rapid technologies for sterility and endotoxin testing together with an automated microbial enumeration system. Microbial testing is performed on batches manufactured as part of a rigorous batch release process.
SCA Pharma’s investment in rapid micro technology supports our commitment to deliver safe and effective medications to patients, as quickly as possible.
In conjunction with our Environmental and Personnel Monitoring program, SCA Pharma also has the capability to perform in-house microbial identification using an automated mass spectrometry system. Our microbial identification program continuously assesses and trends any microbial recoveries from within our classified areas.
Our laboratory is equipped with rapid microbiological technology, including:
- SCANRDI Rapid Sterility Test
- Endosafe-MCS System
- Growth Direct Rapid Micro Testing
MEET OUR QUALITY STAFF
Our quality department is staffed with the best in the business. With over 75 years of collective experience in the pharmaceutical industry, these individuals lead a team that is dedicated to meeting the standards set by the FDA.