- EMA CLEAN-CAPS are specifically processed caps, ensuring a low content of particulate- and bioburden contamination before sterilization.
- EMA CLEAN-CAPS can be provided in “Ready-to-be-sterilized” or “Ready-to-be-used” versions.
- If the capping process happens inside the ASEPTIC CORE, the use of EMA CLEAN-CAPS is appropriate.
EMA Pharmaceuticals delivers a CERTIFICATE OF CONFORMITY (COC) systematically for each batch that certifies that the delivered items have been produced and controlled according to the validated drawings and quality assurance procedures in place. It also attests to their compliance with the agreed specification limits. For EMA CLEAN-CAPS, an additional CERTIFICATE OF ANALYSIS (COA) is issued, providing data of the controls performed on the goods. A CERTIFICATE OF IRRADIATION is delivered with each batch of caps which are “Ready-to-be-used”. It certifies that the validated irradiation process has been applied, assuring a SAL (sterility assurance level) of 106.
Drug Master File (DMF)
Drug Master Files (DMF) have been registered at the US-FDA and Chinese FDA authorities for EMA’s Push-Off product range.
Those files contain the relevant information regarding the seal design, manufacturing and processing.
For our customers who have to register their product at the relevant authorities, we provide the LOA (letter of access) to our DMF within 48 hours after reception of the duly completed request.
Project Development Service
Innovation for an enhanced safety of the sterile product Improving global product safety and ease of use is our absolute priority. It can be achieved through innovation in design or process, improving machinability, cleanliness, product differentiation, enhancing visibility, identification, tamper evidence and user’s convenience and thus user’s confidence. Taking into account our customers’ specific needs, matching them with new technologies and the anticipation of market- and regulatory developments is the day-to-day business of our Project Development Team. For further information or a study of your project, please contact us.
Our network of partner-companies, at the cutting edge of their industry, allows us to provide you with a complete package of complementary solutions :