We manage shared responsibility for validation with our supply chain
We manage shared responsibility for validation with our supply chain

We craft our Single Use System with only the top-notch materials. Every part is labeled with its own unique number and meets strict material standards. In addition, we actively promote communication with vendors, conduct audits and maintain a vendor evaluation program.

When it comes to making sure our products are perfect, we start by checking the raw materials and follow through each step – from manufacturing to assembly.

Our single-use bags are made in facilities that meet the best industry standards, such as ISO 9001 and ISO 13485. They also follow the cGMPs, making sure everything’s industry standard. Our production room meets ISO 14644 standard, which is the top level in cleanliness.

Worried about animal products? Don’t be! Our system’s film doesn’t contain any animal-derived components. Any parts that might touch the product are either free from animal materials or follow strict European guidelines to keep things safe and sound, especially against any brain-related diseases from animals.

Each Single Use System comes with a certificate showing it’s authentic. It lists the product’s name, part number, batch number, when it was made, when it expires, how to store it, and info on sterilization. The certificate also proves the product passed a range of stringent tests. A sample Certificate of Conformance is available upon request.


ISO 9001:2015
ISO 13485:2016
EN ISO 13485:2016



See our Validation guide

Product Testing

Product testing for consistently outstanding quality