extractables and leachables (e&l) study is to investigate whether there will be mutual or unilateral migration between drug packaging materials and drugs, thus affecting the quality of drugs. the purpose is to confirm through compatibility tests, the quality of drugs in the selected packaging materials is stable, controllable, so that the safety and effectivity can be guaranteed during the period of validity.we can provide high-quality customized drug compatibility research services to determine suitable packaging systems, production components and drug delivery devices for products. the research report can meet the requirements for multi-country drug registration.
container closure integrity test (ccit) is a method to test whether a package is sealed to a specific level. we carry out two kinds of methods to validate (deterministic and probabilistic methods.
● extractables and leachables (e&l) study, such as ampoules, vials, infusion bottles, prefilled syringes, cartridges, plastic bottles(polyester/polyolefin, with gasket), drug delivery devices, manufacturing in-process components, etc.
● container closure integrity testing (ccit) (vacuum decay method, microbial challenge method, color water method)
tel: 86-400 821 5138
fax: 86-21 3327 5843
email:noa@noagroup.com