ispe - aseptic filling line - njchapterpaulmelamudpres[1]
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8/15/2019 ISPE - Aseptic Filling Line - NJChapterPaulMelamudPres[1]
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FDA on Process Validation 2010 :“The collection and evaluation of data, fromthe process design stage throughoutpro uc on, w c es a s es sc en cevidence that a process is capable of
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“ ” Strength, Identity, Safety, Purity, QualityIncludes roduct attributes & data inte rit
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Installation Qualification (IQ)
Verifies the aspects of a facility, utility, or equipmentthat can affect product quality adhere to approveds ecifications e. . construction materials and are correctly installed
Operational Qualification (OQ)Challenges the functionality of critical components,to show they are capable of operating withinrequired limits and tolerances
Performance Qualification (PQ)Testing the overall capability of the equipment or
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samples in a normal operating environment
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Assume this ase tic fillin line has
already been installed as you see ithere.A group will be created for eachstation to analyze and propose anI / approach to validate that theline can package the client’s products
me approx mate :30 minutes in groups3-5 minutes to report afterwards
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E ui ment rocesses and roducts
that are in scopeCritical Qualit Attributes CQAimparted to the product and/or data at
each stationCritical Process Parameters (CPP)that allow control of the CQACritical In-Process Controls (CIPC)monitor CQA or CPP at each station
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Process – as demoed for the ase tic
filling line, with the following stations:Vial washing – pre-configured programSterilizing tunnel – fixed speed
Powder filling – dry antibiotic powderCheckweighing – pre-fill and post-fillStoppering – with 20mm full-insertion
s oppersCrimping – 20mm aluminum seals with a
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Product – client bought line to run:
Molded vial sizes: 10, 15 & 20mLFill wei ht ran e: 250m – 2.5 ofantibiotic dry powder Minimum throu h ut desired:
120, 100, & 80 vials/min respectivelySterilization: standard re ’s:
(≥ 5min @ 320°C, laminar flow,discharge ≤ 25°C)
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As suggested on the form handouts:Materials of Construction, Welds, and Lubricants(product contact)Ma or hardware com onents model #s serial #s, design / nameplate ratings, etc.)
Major software / automation components (what
Calibration for “critical” instrumentationGMP/Quality System programs (Maintenance,Calibration, Logbooks, SOPs, Training, etc.)Drawing, wiring & code walkthroughs
considerations relevant to product quality
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Critical Quality Attributes (CQA)
Critical Process Parameters (CPP)Critical In-Process Controls CIPC
Identif these as art of our re ort:Ask: why is this station here?Ask: what controls can an operatormanipulate and why might they do so?Ask: what do the sensors do and why?
s : w at s at r s a component a s
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Out of scope for the workshop, but
think about:Normal operating ranges ofequipment + line as a whole
Bracketing “worst case” inputparameters for testingNumber of replicates to demonstrateprocess delivers “consistent”quality for each (or across) productsStatistical Approaches & Sampling
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1) Briefly describe your station and its CQA, CPP,
2) IQ Teams: assume installation is alreadycompleted and the instruments are calibrated.
a nee s or your s a on3) OQ Teams: describe what functionality needs OQ
es eciall those relevant to the CPP, and CIPC4) Consider what process and product combinations
will need to be run for your station to demonstrate
acceptable CQA under normal operatingconditions (PQ)
. , ,walk around to each station to answer anyquestions you may have
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Paul A. Melamud
[email protected], x2008
Scott Collins [email protected], x2110
QPharma Inc.22 South StreetMorristown, NJ 07960
www.qpharmacorp.com