Sharp Sterile is committed to quality and scientific excellence. We work with you to transfer your methods, develop more reliable and durable methods, and put your product up on stability to test its shelf life. We have an extensive array of analytical equipment available that has undergone the rigors of qualification and validation to ensure your analytical drug testing meets cGMP standards. We also work with your chosen outside vendors to enable you the most cost effective path through drug development and ultimately commercial release. Communication is critical to Sharp Sterile, and we provide weekly updates on on-going programs and interim reports through stability programs.
Stability and Release Testing
Sharp Sterile prides itself on our flexibility and responsiveness in designing and monitoring your stability studies, while keeping the integrity of your data at the highest level. We work with your analytical team to develop stability protocols that are specific to the needs of your study. Sharp Sterile will design these with set pull points, incubation temperatures, and testing requirements for each pull point. A final report will be provided at the end of each study but you can also receive interim reports throughout the stability study after review and approval from our quality department. The validated chambers that are available to clients for storage are listed below, but if you need an additional temperature point that we do not currently have, Sharp Sterile will install, map and validate new chamber(s) as requested. We work closely with you and our quality department to ensure that your study is designed to give you the most effective measures of your drug’s stability.
| Incubator Temperature | Humidity | Size |
|---|---|---|
| -20°C | N/A | Walk-in 8’x10′ |
| 2–8°C | N/A | Walk-in 8’x10′ |
| 25°C ±2°C | 60% ±5% | Walk-in 8’x10′ |
| 40°C ±2°C | 60% ±5% | 150 sq. ft. |
Raw Material In-Process Release Testing
Method Transfer & Validation
All new drugs require appropriate tests for accurate measurement of their ID and concentration. Your assay must be resilient to produce consistent and reliable results. Sharp Sterile has the analytical expertise to transfer and improve your methods to make them durable. This work is performed under the oversight of Sharp Sterile’s Quality Control team and review by our Quality Assurance group. We issue Certificates of Analysis (CoA) with the documentation necessary to stand up to a stringent review.
Assay or Validation / Transfer or Validation
Sharp Sterile performs method transfers. Our qualifications involve site to site assays and multiple analyst test to ensure results are consistent. If your test does not meet GLP or GMP standards, our analytical staff will work with you to develop a robust assay for standard testing that will guarantee purity, quality, and strength each time the assay is performed.
