ANALYTICAL & LAB EQUIPMENT


USING MOCKUPS FOR CONTAMINATION CONTROL


Mockups, often made from wood or cardboard, can help mitigate installation problems further down the line. Saskia Henn reports


During the implementation of a new aseptic fi lling line, adequate preparation is necessary to prevent operational shutdown at a later stage By Saskia Hems


I mplementing a new aseptic


fi lling line can be daunting, since everything from the layout of the cleanroom to the height of the


operators can infl uence how well your contamination control management system works. A recent webinar titled ‘The


Successful Implementation of a New Aseptic Filling Line,’ outlined how diff icult it can be, as well as how technicians can prevent issues further down the line. The webinar was hosted by Mark


Hallworth, the pharmaceutical manager for PMS, and Marc Machauer, global OEM coordinator for the company. As Hallworth explained, although risk assessment can ensure that regulatory requirements are met, this process often occurs at the end of fi lling line implementation once it is hard to change anything – such an assessment is therefore not enough to mitigate operational problems. Rather than relying on risk


assessment, operators should ensure they prepare adequately for the build before it goes ahead because once a design is complete, it is often replicated and sold to pharma companies that must adapt their own process to the machine. It can be diff icult to make a specialised product work for someone else.


Operators should prepare adequately for a build before it starts Hallworth recommends that lab


operators invest time and resources into a facility right from the beginning and that they create an adequate mock up. This will make it less likely that something will need to be retrofi tted.


RESOLVING BAD INSTALLATION ISSUES Machauer explained that he often sees fi lling lines that have amendments once they are installed as well as the problems that occur. “Many times, we get pulled in after a


machine is installed and the customer has come to us, and now we have to make it work somehow,” he said. “It is expensive and time consuming


to resolve the issue from this standpoint.” This is why the mock-up phase


is so important. The physical representation of a machine provides a realistic idea of what the fi nal product will look like. Mock-ups are commonly made virtually or from wood, cardboard and foam core, allowing designers to quickly make changes as needed. This type of testing can help


operators understand what the risks are, where the airfl ow patterns are and what changes need to occur prior to installation.


Hallworth said: “A process study


for each phase of the machine will give us many sample points that refl ect the best risk within that environment.” During the mock-up phase,


operators of diff erent heights can reach into the machine to pick up microbial plates and test if they work smoothly. This simulation testing can also be applied to automated equipment, such as robotic arms. “It’s always better to do a wood


model where you can put in some real components and you have a real reach,” said Machauer. An accurate mock-up can prevent


problems leading to operational shutdown later on, such as on-site modifi cations, measurements not adding up or problems with the physical space where the fi lling line sits. www.pmeasuring.com “We’ve got this whole quality


by design strategy. Rather than trying to measure for quality at the end, we’ve got to push that quality forward into the design and mock- up phase,” said Hallworth.


For more information visit: www.pmeasuring.com


www.scientistlive.com 15


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52