Is the Crystal® Technology supported by FDA and EMEA?
EMEA and FDA have been informed of the project since the very beginning and did not raise any major concern. Presentations have been made to both of them and the outcome was that no concern was raised regarding the technology.
Is the Validation Master Plan completed?
Yes (ICH ageing studies are on-going), all validation results are available to support our customers to validate a Crystal® Filling Line or register a product in the Closed Vial. To ensure that vials meet expectations in irradiation worst case, the validation master plan has been conducted with 50 kGray irradiated vials.
What about extractables and leachables ?
Extensive tests have been performed to first identify extractables from both COC body and TPE stopper, and then to measure leachables in different simulants, as for instance WFI, phenoxyethanol 0,5% and ethanol 10%. All results are consistent and show that very few substances are leached (mainly some ppm of weak acids), without any toxicity concern. Please note that all these tests have been performed using vials gamma irradiated at the maximum practical dose, i.e. 50 kGray.
Is a Crystal® Filling Line approved by EMEA and/or FDA?
The first Crystal® Filling Line (a Clinical Line, operated by Aseptic Technologies) has been inspected and approved as a GMP manufacturing site by EMEA in 2007; a DMF has been filed at the FDA (CDER and CBER).
In the US, Parenteral Innovations has been registered at FDA as contract manufacturer using the Crystal® Technology (operating a Clinical Line).
Are there on-going stability tests?
Research compatibility and official stability batches have been launched for many different products from different pharma and biotech companies. Results have shown an improved stability in many occasions.
Is my product stable in the closed vial?
Easy to test, please contact us to be aware of the different options and evaluate the best solution to conduct a test with the Crystal® Technology.
Who is using Crystal® Technology?
Lonza Walkersville;
The Netherlands Vaccine Institute;
Vivante GMP Solutions.