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     Theory intoPractice

    David Clarke BSc (Hons), MSc

    Physics

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    Stability Testing: Theoryinto Practice• Reglations overvie!

    • "b#ectives o$ Stability Testing

    • Testing Protocols

    •%nter&retation o$ reslts

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    Reglations "vervie!•

    Cos'etic Prodct 'st be sa$e $or h'an health• Proven by Cos'etic Prodct Sa$ety Re&ort (CPSR)

    • Re&ort inclded in P%

    • Part * Cos'etic Prodct Sa$ety %n$or'ation

    • +antitative -alitative co'&osition

    Physical.che'ical characteristics &rodct stability• Microbiological -ality

    • %'&rities, traces, &ackaging in$or'ation &ackagingstability

    • /or'al.$oreseeable se

    • Prodct.sbstance e0&osre

    •  To0icological &ro1le

    • 2ndesirable.seriosly ndesirable e3ects

    • "ther in$or'ation

    • Part B * Cos'etic Prodct Sa$ety ssess'ent

    • Conclsions $ro' Part

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    Reglations "vervie!

    • 4abelling

    • Date o$ Mini'' Drability

    • %$ Date o$ Mini'' Drability e0ceeds 56

    'onths• P"

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    Reglations "vervie!

    • 7age re-ire'ents

    • Testing condcted shold be s&eci1c to the&rodct and the ty&e o$ data re-ired $ro' it8

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    "b#ectives o$ Stability Testing

    • De1nition * 9Deter'ine !hether a particularformulation, in its immediate packagingcan retain its intended physical & chemicalstability and microbiological quality,

    inclding its intended function andaesthetics nder the conditions of themarket in !hich it is to be sold8

    • 2nderstand ho! the &rodct shall $air over

    ti'e• Pri'ary concern * sa$ety

    • Secondary concern * Brand . Man$actrerre&tation

    • t !hat &oint are changes nacce&table;

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    "b#ectives o$ Stability Testing

    • Prodct Stability * Prodct stored and tested

    in inert, i'&er'eable glass #ars

    • Container Co'&atibility * Prodct and the

    1nal, i''ediate &ackaging tested together

    • Reco''end condcting both stability and

    co'&atibility• Deter'ines &rodct or &ackaging instability

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     Ty&es o$ Stability Tests

    • Real Ti'e Stability Testing

    • Stored in actal 'arket conditions $or the

    dration o$ 'ini'' drability

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     Ty&es o$ Stability Tests

    • ccelerated Stability Testing

    • Stored nder varios conditions to accelerate

    changes occrring nder nor'al conditions *

    &redicts stability

    • Bene1ts * data ac-ired relatively -ickly

    • Disadvantages *

    • %nstabilities in real ti'e testing 'ay not occr in

    accelerated testing

    • Harsher conditions 'ay reslt in degradation that

    !old never occr nder nor'al conditions

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     Te'&eratre

    • n increase o$ ?6@C $ro' a'bient

    te'&eratre dobles the rate o$ reaction

    • 'bient > A6@C

    • 6@C stored $or 5 'onths

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     Te'&eratre

    • lternate rti1cial ging ides

    • ?A !eeks at @C e-ates to A 'onths

    • ?A !eeks at @C e-ates to 56 'onths

    • ?E !eeks at @C e-ates to 56 'onths

    • ides deter'ined by the Brand .Man$actrer * Fhat do yo think is

    acce&table;• Fhere is the intended 'arket;

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     Te'&eratre

    • Sa'&les stored at chilled te'&eratre *Control

    • 2sed $or co'&arisons

    • So'e sa'&les stored as close to the a'bient'arket conditions

    • ssess roo' te'&eratre stability

    • Store in dark conditions

    • Storage conditions 'st be controlled

    •  Te'& control range, Gctations variations

    • Storage te'&eratre 'onitored daily

    • Calibrate 'onitoring e-i&'ent reglarly

    • 68@C, ?86@C %ncbator . $ridge constraints;

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    Relative H'idity

    • %''ediate &ackaging test (co'&atibility)

    • Does the &ack &rovide ade-ate &rotection;

    • chieved sing satrated salt soltions in a sealedcha'ber

    • Control at a'bient

    • Test at h'id dry conditions

    • Monitor daily

    • Calibrate 'onitoring e-i&'ent

    Satrated

    Soltion

     Te'&eratre @C

    ?6 A6 56 6

    I/"5 J J5 J? KK

    /aC4 LE LE L LI AC"5 L 5 A

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    Cycling . reee Tha! Tests

    • lctating conditions at reglar intervals canbe 'ore stress$l than constant conditions

    • Cycling

    • 'bient N 6@C N 'bient over A hors

    •   reee Tha!

    • >?6@C N 6@C N >?6@C over A hors

    • A !eek test ti'e

    • Consider trans&ort . storage conditions

    • 4ikely to be 'ore severe than yo antici&ated

    • Set te'&eratre controller to cycle bet!eente'&eratres

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    4ight

    • Photostability o$ &rodct and i''ediate&ackaging

    • Findo! light 'ethod• /atral daylight * /orth $acing

    • Mini'ise direct snlight

    • Co'&are to controlled sa'&les ke&t in darkcondition

    • Dark incbator

    • "RO Fra&&ed in al'ini' $oil

    • Consider season and !eather variations as ite3ects the intensity o$ light

    /ot a controlled 'ethod

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    4ight

    • ccelerated light 'ethod

    • 4ight cabinet * SnTest CPS

    • 4a'& covers !hole or broad s&ectr' o$ light

    • e8g8 Qenon la'&

    • 7arios 1lters available * 27

    • 2tilise cooling syste' * re'ove e3ects cased

    by te'&eratre

    • Record data * radiant e0&osre, te'&eratre

    and ti'e

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    4ight•

    Control sa'&le !ra&&ed in al'ini' $oil

    • Test sa'&le e0&osed to light

    • Test &rotocols

    6F.'A

    !ith C grade 1lter (!indo!), A 0 ?6 hore0&osre (A tests)

    • 6F.'A !ith C grade 1lter (!indo!), 5 hor to

    'a0i'' ?A hor e0&osre (&otentially tests)

    • 6F.'A !ith C grade 1lter (!indo!), L 0 ?6 hor

    e0&osre (L tests)

    • 6F.'A !ith C grade 1lter (!indo!), A6 hor

    e0&osre (? test)

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     Test Points•

    %nitial readings•

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    7ol'e . Pack /'berRe-ire'ents• De&endant on

    • /'ber o$ test conditions

    • /'ber o$ test &oints

    •  Tests re-ired

    • Prodct ty&e

    • Make 'ore than yo think yo need

    • Retest the sa'e sa'&le . &ack throghottest;

    • Si'lates cons'er sage

    • "RO test ne! sa'&le . &ack at each test∮

    • Si'lates &rodct o&ened $or the 1rst ti'e

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    %nter&retation

    • Prodct s&eci1cations• otside o$ s&eci1cation * nsatis$actory *

    re$or'late . ne! &ack

    • Fere the s&eci1cations too narro!;

    • ccelerated test• changes observed an accrate &rediction o$

    arti1cial ageing;

    • "RO changes de to conditions being too $ar

    re'oved $ro' the reasonably $oreseeableconditions;

    • Does the &rodct retain its initial $nction andre'ain sa$e;

    • re the changes aesthetic;