All our products are designed and manufactured to provide more efficient, secured and easier solutions to meet the latest regulatory requirements.

From the origins of the company, we genuinely work with Regulatory Agencies, presenting them our concepts, sharing our data and incorporating their feedback in our development validations. Since then, we maintain regular meetings with these bodies and their inspectors.

Request support for your Regulatory Affairs

To intensify the information exchange within the pharmaceutical industry and also to present and discuss our innovations, we are active members of various institutions, such as:


AT-Closed Vial® Technology

Drug Master Files

Drug Master Files (DMF) have been registered to the American FDA for AT-Closed Vial® and AT- Cap™.

Data under CDA

Vial body and stopper materials; Leachable and Extractable studies; Content of Validation Master Plan; Vial Manufacturing.

Validation Master Plan

To validate the AT-Closed Vial® Technology, we performed a Validation Master Plan (VMP), based on the USP (United States Pharmacopeia), Ph. Eur. (European Pharmacopeia) and... Read more

Liquid transfer systems

AT-Connector™ System

Validation and QC

Several validation tests were performed on the AT-Connector™ System. Some of these are performed regularly, other were performed during initial validation tests. Read more

Certificate of Conformity

All supplied disposable connector devices are released by our Qualified Person. Read more

AT-Filling Kit™

Manufacturing Conditions

AT-Filling Kits™ are manufactured in airborne particle classification ISO7.

Certificate of Conformity

All supplied AT-Filling Kits™ are released by our Qualified Person. Read more

Users community

The community of users of our technology consists of Big Pharma, Biotech, University Laboratories and Hospital Pharmacies.

Having used the conventional glass vial/stopper/crimp vialing system on many projects, I was faced with limitations, risks and operational challenges. After reviewing and using the Aseptic Technologies vials and filling systems many of those challenges are resolved. The filling system has less moving parts which means less chances of the machine jamming and halting filling operations. Since the vials come ready for use there is no need for cleaning and sterilization of the vials. Aseptic Technologies also offers great installation, commissioning and validation services and assistance.

Mike O'Mara
DynPort Vaccine Company LCC, a CSRA Company

Aseptic Technologies vials are well suited for hospital pharmacy preparations in batches. They provide a high quality standard material, allowing a filling in a closed system insuring microbiological safety as well as an absence of particulate matter. The system is ergonomic to use and appreciated by our production operators. These qualities have incited us to progressively increase the number of products conditioned in these vials

Pascal Bonnabry
Head of pharmacy, Geneva University Hospitals, Geneva, Switzerland

Aseptic Technologies vials are well suited for Cell Therapy applications: they provide the quality standards for creating a pharmaceutical product, and the closed filling process provides greater sterility assurance compared to open vials. The company has supported applications with a range of lot sizes - enabling Cell Therapies across the scalability spectrum

Jon Rowley
Former Innovation Director of Lonza's Cell Therapy Business, current CEO of RoosterBio, Inc

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