Fill Line Qualification

Aseptic Liquid Filling Line

Hello, good people of the world! This post is about aseptic liquid vial fill line qualifications. I’ve seen a few of these in my time, and in some ways they’re easier to qualify than other systems, in some ways more challenging. Fill lines may be easier because these systems are typically off-the-shelf with less customization. They may be more complicated because you’re dealing with a lot of interconnected equipment and automated control.

I’ve worked with Bausch-Stroebel (bausch-stroebel.com) and Bosch (bosch.com) fill lines, but TurboFil, Marchesini, and IMA are also common vendors.

The standard components of an aseptic liquid vial fill are: Trayloader/Unloader, Vial Washer, Depyrogenation Tunnel, Filler, Checkweigher, Stopperer, and Capper.

What considerations do you always keep in mind? Leave a comment below and please share this post with whomever you think would benefit..

The Validation Department – a Producer of Data

Data Production

Hello, good people of the world! So you’re in Validation. Or any part of the Quality department. You don’t manufacture anything, you don’t sell anything – what is your role?

You are in the business of information, and you have many customers. Your first and most important customer may be the regulatory agencies your product(s) are subject to, but you’re also serving Manufacturing, Engineering, and the company owners and shareholders. That means you better be good at handling information. Continue reading The Validation Department – a Producer of Data

Recovery Studies – What the Heck?!

Recovery

Hello, good people of the world! Recovery studies are studies to support surface swab processes. They typically involve “spiking” a “coupon” made from a particular material with a known amount of the contaminate you’re interested in, and then systematically quantifying the amount recovered via the swab process.

You’ll need to perform recovery studies for all product-contact materials you have in your manufacturing process. These typically include 316L stainless steel, PTFE, glass, etc.

Quality Metrics

Metrics
Metrics

Hello, good people of the world! If you know me, then you know I’m into “metrics” – ways to evaluate the health of a system or process quantitatively. We know finding and correctly interpreting the “right” metrics is not trivial, and looking at the “wrong” metrics can do more harm then good.

ISPE has recently released a whitepaper suggesting quality metrics for the FDA to use in their inspection process. I’ve uploaded a copy Continue reading Quality Metrics

Stability – What is it and Why is it Important

Stabliity

Hello, good people of the world! Stability is the characteristic of your drug product to withstand degradation or changes due to environment factors, typically temperature, humidity, and light.

World Health Organisation (WHO) has published guidelines addressing drug stability since 1996. WHO introduced the concept of 4 climatic zones, derived from a scientific paper published in 1993: Grimm, W., Drug Development and Industrial Pharmacy (1993) 19:2795-2830. Continue reading Stability – What is it and Why is it Important