The importance of cleanrooms is currently in the spotlight as the global community awaits a vaccine for Covid-19. Laboratories need controlled environments that are contamination free in order to carry out development and testing that produces reliable test results.
A cleanroom is classified according to the level of cleanliness of the air inside it. The class is assigned based on the quantity and size of particles per volume of air expressed in microns (µm). ISO 14644-1, the standard used in the United States and Canada and other countries around the world, defines the requirements for cleanroom classes ISO 1-9, with the most common being ISO 7 and ISO 8.
In a test performed by Colandis GmbH in Kahla, Germany, particle emissions were measured on the zwickiLine Z0.5, Z1.0 and Z2.5 materials testing machines. The results showed that these materials testing machines can be used in production and testing areas of cleanroom classes 5 and 6.
Cleanroom suitability of the materials testing machines was validated according to DIN EN ISO 14644 1:2016-06, DIN EN ISO 14644-14 and VDI 2083-9.1.
With this validation, pharmaceutical companies can integrate the testing of syringes and containers such as vials in the production process in the cleanroom, eliminating the need for the transfer of samples from the cleanroom to the testing lab.
ZwickRoell offers the zwickiLine testing machine family for a wide range of requirements in testing medical and pharmaceutical products and devices. Two of particular importance today, as pharmaceutical companies work towards a vaccine for Covid-19, are the standard zwickiLine solution for the testing of sterile hypodermic syringes for single use according to ISO 7886-1 and prefilled syringes according to ISO 11040-4 / -6 and -8. One of the most common tests measures break away and glide force, which impact how a vaccine is administered while obtaining the proper effective dose.
The efficient testing of vials involves a residual seal force (RSF) test. ZwickRoell‘s testing system with testXpert III software for traceable and tamper-proof test results in accordance with FDA 21 CFR Part 11 ensures industry standards are met. With ZwickRoell’s testXpert III, you can ensure the authenticity and integrity of your data within testXpert III by using the Traceability option. It offers the possibility to configure the scope of logging (audit trail) according to your requirements and it includes the electronic signature functions in testXpert III.
Although it is still unknown when an approved vaccine will be released, pharmaceutical companies understand the importance of sterile products and environments to ensure the efficient and reliable mass manufacturing of the vaccine—two key factors in the fight against the Coronavirus.
For more information, contact Michael Goehring, Industry Manager for Medical and Pharmaceutical in North America or visit www.zwickroell.com.