MED GUID ulding, fu
When it comes to product qualiity in injection moulding, machine and tool validation is fundamental to creating a stable manufacturing process and de-risking the project. Yet, it’s often bureaucracy rather than methodology that drives companies to validate. James Hines, process and training engineer at Sumitomo (SHI) Demag goesma back to the basics of why we vallidate and why this complex process shouldn’t be just regarded as a tick- ox exercise to get the FD or oth regulatory bodies off your back
IDE TO INJE it co
s to
INJECTI O t q
amental to creatin a stable m
com anies to validate. Jam s H aining engine er at ck to th
sics of w y w ty in injectio achi e and tool val dation i factu in
process and de-ri king the project. Yet, bureaucracy rather than
mi mo id te often
ethodology that drives s, process an
goes y this
com x process shoul n’t be j st regarded as a tick-box exercise to get the FDA or other regulatory bodies off your back
T
owards the end of 2015 the European Commission issued its first update
since 2001, causing more confusion. Th e new version of Annex 15 now requires manufacturers to ensure that ‘critical aspects’ of their operation are validated throughout the product lifecycle. This includes any changes that could impact a product’s quality. Effective 1 October 2015, the amendment to EurdraLex
Validation closely mirror th Volume 4, Annex 15: Qualif
ication and e FDA’s
lifecycle approach. There’s also a greater emphasis on risk management to reflect today’s manufacturing an d regulator y environment. So, how do these changes impact manufacturers of pharmaceutical components? As before, there are three key phases to process validation, only now the FDA categorises them as Process Design, Process Qualification, and Continued Process Verification. These reflect the focus on the manufacturing lifecycle and the need to provide scientifically sound data to verify that your injection moulding processes star t and continue to remain st able .
WHY VALI ATE? HY VALIDAT TE?
exists, it’s to ensure that inj Going back to the basics of
nj moulders have a stable and why validation
dimensionally ection
centred process that consistently
produces high quality products. Validation is basically providing the scientific evidence that themachine and tool is repeatedly doing everything you expect it to do everyminute of every day. For any plastics manufacturer, zero defects remain the target. In the medical industry, there’s no wiggle room. You can’t shift the parameters to suit.
,
sterile implant, nothing les you’re producing a medical
cent quality is acceptable.
The validation process requires a step- by-step approach, working with each customer to break down each element of each injection moulding cycle and
documenting every stage. Conducted by an engineer, the actual validation usually takes longer than actually building the tool itself. For this reason, the validation is often partially c toolmakers’ facilit
y by a senior engineer ompleted at the
from the company as this allows issues to be addressed there and then on site, rather than shipping the tool back and forth. Ultimately, the final phases of the validation will be completed in-house on the specified equipment.
In some instances, it can be beneficial for customers to bring their moulding tools to our facility in either the UK or at in our application centre in Germany for validation, especially if you are acquiring a new machine and want to see how the application performs in realistic proces s conditions.
BREAKING DOWN EACH PHASE At the Process Design stage you are looking to see if you have the proper sized machine - shot size and tonnage - and that the equipment is properly calibrated. During the Process
BREAKING DOWN EACH PHASE
Qualification phase, you will move on to establish the range of process
parameters. This involves conducting a selection of statistical and dimensional studies, enabling you to identify and investigate any deviations in the process. A process is not considered as validated if the variations have negatively impacted the finished product in any way.
s than 100 per device or a If
The final validation phase - Continued Process Verification - focuses on demonstrating that your process is
consistently stable. It involves simulating different production runs using the same
/AUTOMATIONATION /AUTOMAT For plastics or plastics
manufacturers zero defects is the target, particularly within the pharmaceutical industr where qual paramount
manufacturers zero defects is the target, particularly within the pharmaceutical industry where quality isity is paramount
James Hines, process & training engineer at Sumitomo (S I) Demag UK
James Hines, process & training engineer at Sumitomo (SHI) Demag UK
Va Validation is the alidation is the
scientific evidence that the IM machine and tool is repeatedly doing what’s expected
scientific evidence that the IM machine and tool is repeatedly doing what’s expected
production equipment and the processes that you will be routinely using, ensuring repeatability of the se throughout the machi
ne’s full lifecycle. t-up conditions
In accordance with ISO 13485
standards, ongoing documentation of the injection moulding process needs to be maintained. This is a continuous process, which is a significant change under the new directive. From time to time, machine settings may have to be adjusted to compensate for changes in the environment or to address moulding issues, such as pulling, distortion, or aesthetic defects. The key areas that might impact a stable process include changes in pressure, temperature, flow rate and cooling rates, any of which may trigger a re-validation exercise Major repairs, changes, or
improvements to the mould tool ma y require changes in the set up, and this would mean re-validating the process. This is also true of the moulding
machines. Significant repairs or machine exchanges if not carefully managed and controlled may trigger a full validation of the process, which takes time and costs the moulder more m oney .
OTHER CONSIDERATIONS HER CONSIDERATIONS
Before you start validating, it is vital to be clear on your expectati provide a documented
source of evidence ons. If it’s to
bjective of having an efficient process and repeatable high product quality should never be overlooked, as this is ultimately how you can avoid costly product recalls and cosmetic product defect s.
to satisfy a regulatory body, you need to do it. But that shouldn’t be your sole motivation. Validation is not purely about procedures and scrambling to put the correct documentation in place. The obj
From a business perspective, validation will also address profit-driven challenges and design out production weaknesses.
T: 01296 739500 http:
Sumitomo (SHI) Demag T: 01296 739500
http://uk.sumitomo-shi-demag.eu AU AUTOMA MAT ATION | MARCH 201 MAR
k.sumtom
-shi-demag.eu 2017 13 13
MEDICAL EQU PMENUIPI MENT
INDUSTRY F
STRY FO CUS IONMOULDING VALIDVALIDATIO ION
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