Hello good people of the world! So every project needs to track open items and that is typically done with a punchlist. You may have seen a punchlist in a Microsoft Excel spreadsheet, with one person as the owner, or even worse, on pen and paper.
A punchlist is a collection of data, and any good data collection is:
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Hello good people of the world! Today’s post is on the commissioning and qualification of instruments used in process measurement and control. Instruments may be used to measure such things as flow, temperature, pressure, level, weight, conductivity, etc. In use, many of these parameters may be quality critical, so proper commissioning and qualification is key! Continue reading Commissioning and Qualification of Process Instrumentation
Hello good people of the world! This blog post covers Construction Quality Assurance, based on an article that appeared in the Nov/Dec 2012 edition of Pharmaceutical Engineering titled “Assured Construction Quality Saves Time and Money.” All credit goes to the authors: Jay Lad of Skanska Pharmaceutical Group and Bruce Beck of Eli Lilly. Continue reading Quality During Construction
Hello good people of the world! If you work with a mix of process equipment and supervisory control or monitoring systems, you know the importance of alerts and alarms, but most companies do not take the necessary steps to ensure their alerts and alarms are well configured and meaningful. One of the enemies is so-called “nuisance-alarms,” but just as important is knowing that you have enough alerting/alarming so that critical events are not missed and appropriate actions are taken before harm is done.
And by the way, alerts and alarms are something the FDA has historically shown to care about (e.g. FDA had observation at Teva Irvine for lack of validation on alerts and alarms). So what considerations are at play?
What should alert/alarm? If you’ve clearly defined your Critical Process Parameters (CPPs) and know what your Critical Quality Attributes (CQAs) are, you know already what needs alerts/alarms: all CPPs.
What should the alert/alarm limits be? This part is tricky: you need limits that provide operators with sufficient information without becoming a nuisance. All too often I see the situation where alarm banners are flashing but no one is paying attention because “there’s always alarms” or whatever.
What action should occur based on alert/alarm conditions? This is another place I often see improvements needed: every alert and alarm should have a documented action associated with it, typically in the SOP, that operators are trained on. If there is no documented action required for an alert/alarm, why do you have it?
What do you find critical in configuring alerts/alarms and introducing them into a manufacturing process?
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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..