Newsletter | May 9, 2024

05.09.24 -- Let's deviate from deviations - Sterile drugs.

5 areas to focus your QRM strategy-sterile drug products

Everyone enjoys driving when there is no traffic. When the roads are clear, the tarmac is smooth, and every traffic light is green. No need to touch the brakes, let’s go! But this isn’t reality. A crash ahead makes you deviate to a longer route. You may be late for work! We can’t avoid deviations completely, but within the confines of a drug manufacturing process it is not only beneficial for us to mitigate risk, it is our duty.


Building an effective CCS for sterile filtration

Developing a contamination control strategy (CCS) is essential to aseptic manufacturing, with final sterile filtration playing a key role in assuring quality, safe, and compliant product. Join our latest webinar as we discuss these considerations in terms of risk assessment, regulatory compliance, and pre-use post-sterilization integrity testing (PUPSIT).


Risk control | Bulk filling application

In this virtual event, we introduce a bulk filling system and share how you can achieve risk control, accuracy, and excellent product recovery for fill and finish operations. We will also highlight the extensive configuration options available. Natasha Kelly and Simonas Juodis from the Cytiva R&D team will run a demonstration of the system.


Bulk filling of drug substance | Accurate aliquoting

Current systems/methods dispense fluid with limited capability, using complex flow paths, creating opportunities for product hold-up and increased risk of batch deviation due to manual process. Here, we demonstrate the performance of a fully closed, bulk filling system and the accuracy of dispensing a range of drug substances with scaling viscosities, into variable-sized biocontainer bags or bottles.