ISPE - Aseptic Filling Line - NJChapterPaulMelamudPres[1]

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

”

“ ” 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

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ISPE - Aseptic Filling Line - NJChapterPaulMelamudPres[1]