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.
Compliance
Regulatory
All our products are designed and manufactured to provide more efficient, secured and easier solutions to meet the latest regulatory requirements.
"Certain modern manufacturing designs (isolators and closed vial filling) afford isolation of the aseptic process from microbiological contamination risks throughout processing. For such closed systems, if the design of the processing equipment is robust and the extent of manual manipulation in the manufacturing process is minimized, a firm can consider this information in determining its media fill validation approach."
- FDA, Questions and Answers on Current Good Manufacturing Practices—Production and Process Controls
"…very interesting innovative technique…”
- CHMP recommendation to approval by EMA of Synflorix™, GSK vaccine in the AT-Closed Vial®
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:
Validation
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-Connector™ System Validation Guide
Tests conducted for initial validation
Leak test after ageing;
Leak test after multiple opening/closures;
Fitting and traction test
Burst pressure test;
Packaging integrity test;
Particle detection;
USP Class VI criteria;
Extractable profile;
Endotoxin Contamination;
Media fill simulation in worst case condition.
AT-Port™ (external and internal Ports)
The ports are systematically tested to ensure that they meet cGMP criteria:
Visual inspection:
Critical dimensions;
Air leak test;
Functionality.
AT-Connector™ (Connector Device)
100% individual tests
Packaging identification;
Air leak test on closed connectors.
Routine tests on random samples
Critical dimensions;
Weight;
Visual inspection.
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.
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
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
