{"id":2691,"date":"2026-01-13T17:27:36","date_gmt":"2026-01-13T09:27:36","guid":{"rendered":"https:\/\/glassbottlesupplies.com\/?p=2691"},"modified":"2026-01-04T17:28:58","modified_gmt":"2026-01-04T09:28:58","slug":"2026-sterilization-protocol-managing-alkalinity-shift-and-thermal-shock-in-glass-bottles-for-injection","status":"publish","type":"post","link":"https:\/\/glassbottlesupplies.com\/fr\/2026-sterilization-protocol-managing-alkalinity-shift-and-thermal-shock-in-glass-bottles-for-injection\/","title":{"rendered":"2026 Protocole de st\u00e9rilisation : Gestion du changement d'alcalinit\u00e9 et du choc thermique dans les flacons en verre pour injection"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Dans la cha\u00eene d'approvisionnement pharmaceutique, les <strong>flacon en verre pour injection<\/strong> est le seul composant qui subit les contraintes thermiques et chimiques les plus extr\u00eames avant de rencontrer le m\u00e9dicament. Il est lav\u00e9 \u00e0 80\u00b0C, d\u00e9pyrog\u00e9n\u00e9is\u00e9 \u00e0 300\u00b0C et souvent st\u00e9rilis\u00e9 \u00e0 121\u00b0C.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pour les acheteurs B2B et les ing\u00e9nieurs qualit\u00e9, le risque n'est pas seulement celui de la casse, mais aussi celui d'une perte de qualit\u00e9. <strong>D\u00e9placement de l'alcalinit\u00e9<\/strong>. Lorsqu'une norme <strong><a href=\"https:\/\/glassbottlesupplies.com\/fr\/category\/product\/injection-bottles\/\"   title=\"Flacons pour injection\"  data-wpil-monitor-id=\"798\">flacon injectable<\/a><\/strong> Sous l'effet de la chaleur, la matrice de verre peut se d\u00e9tendre et lib\u00e9rer des ions sodium dans l'eau pour pr\u00e9parations injectables ou la solution m\u00e9dicamenteuse. Cette migration chimique invisible peut modifier le pH d'une formulation sensible, rendant un lot de vaccins ou d'antibiotiques biologiquement inerte.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ce guide explore la thermodynamique des <strong>injection de bouteilles<\/strong> le traitement sp\u00e9cifique des donn\u00e9es volatiles <strong><a href=\"https:\/\/glassbottlesupplies.com\/fr\/category\/product\/injection-bottles\/\"   title=\"Flacons pour injection\"  data-wpil-monitor-id=\"797\">Flacons d'injection d'\u00e9ther<\/a><\/strong>, et les normes ISO qui d\u00e9finissent la v\u00e9ritable \u201cr\u00e9sistance \u00e0 l'hydrolyse\u201d en 2026.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">La chimie de la chaleur : Pourquoi le verre \u201cinerte\u201d n'est pas toujours inerte<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Lors de l'approvisionnement d'un <strong><a href=\"https:\/\/glassbottlesupplies.com\/fr\/category\/product\/injection-bottles\/\"   title=\"Flacons pour injection\"  data-wpil-monitor-id=\"796\">flacon en verre pour injection<\/a><\/strong>, La fiche de sp\u00e9cification indique que le mat\u00e9riau est de \u201ctype I Borosilicate\u201d ou de \u201ctype II Soda-Lime\u201d. Cependant, le responsable des achats doit comprendre comment ces mat\u00e9riaux se comportent \u00e0 l'int\u00e9rieur d'un tunnel de st\u00e9rilisation.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Le m\u00e9canisme de lixiviation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Le verre n'est pas un solide, c'est un solide amorphe. Il est constitu\u00e9 d'un r\u00e9seau de silice (SiO2) et de bore (B2O3), modifi\u00e9 par des fondants (oxyde de sodium, oxyde de calcium) pour abaisser le point de fusion.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>La menace :<\/strong> Le sodium (Na+) est faiblement retenu dans la structure du verre.<\/li>\n\n\n\n<li><strong>Le d\u00e9clencheur :<\/strong> Chaleur + humidit\u00e9 (autoclavage).<\/li>\n\n\n\n<li><strong>La r\u00e9action :<\/strong> Lorsqu'un <strong>flacon injectable<\/strong> est autoclav\u00e9, la vapeur surchauff\u00e9e attaque la surface du verre. Les ions sodium migrent vers l'ext\u00e9rieur (lessivage) et sont remplac\u00e9s par les ions hydrog\u00e8ne de l'eau.<\/li>\n\n\n\n<li><strong>Le r\u00e9sultat :<\/strong> L'accumulation d'hydroxyde de sodium (NaOH) sur la surface du verre. Si vous remplissez un petit flacon (2 ml ou 5 ml) avec une solution neutre, cette lixiviation peut faire passer le pH de 7,0 \u00e0 9,0 en une nuit.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2026 Protocole d'approvisionnement : Le rapport \u201csurface\/volume<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Le risque de changement d'alcalinit\u00e9 n'est pas lin\u00e9aire.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Grands flacons (100ml+) :<\/strong> Le volume de liquide dilue le sodium lessiv\u00e9. Le changement de pH est n\u00e9gligeable.<\/li>\n\n\n\n<li><strong>Petits flacons (2ml - 10ml) :<\/strong> La surface du verre est \u00e9norme par rapport au minuscule volume de liquide. Le changement de pH est catastrophique.<\/li>\n\n\n\n<li><strong>Le Spec :<\/strong> Pour les petits formats <strong>injection de bouteilles<\/strong> vous devez sp\u00e9cifier <strong>\u201cTrait\u00e9 au sulfate d'ammonium\u201d.\u201d<\/strong> verre ou strictement <strong>\u201cExpansion 33\u201d<\/strong> (\u00e0 haute teneur en bore) de type I. Le verre standard \u201cExpansion 51\u201d ou \u201cExpansion 70\u201d peut ne pas passer le test d'alcalinit\u00e9 pour les petits volumes.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Le d\u00e9fi de l'\u00e9ther : Pression de vapeur et force d'\u00e9clatement<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Approvisionnement <strong>Flacons d'injection d'\u00e9ther<\/strong> est une discipline sp\u00e9cialis\u00e9e en raison de la volatilit\u00e9 de l'\u00e9ther di\u00e9thylique. Contrairement aux m\u00e9dicaments \u00e0 base d'eau, l'\u00e9ther exerce une pression interne massive lorsqu'il est chauff\u00e9.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">L'ing\u00e9nierie \u201cHeadspace<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">L'\u00e9ther bout \u00e0 34,6\u00b0C (94,3\u00b0F). Un entrep\u00f4t en \u00e9t\u00e9 d\u00e9passe facilement cette temp\u00e9rature.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Est-ce que c'est<\/strong> une bouteille standard ?<\/li>\n\n\n\n<li><strong>Pourquoi pas ?<\/strong> Les flacons parent\u00e9raux standard sont con\u00e7us pour une charge verticale (pression de bouchage) et non pour une pression radiale vers l'ext\u00e9rieur (explosion).<\/li>\n\n\n\n<li><strong>La conception :<\/strong> <strong>Bouteilles d'injection d'\u00e9ther<\/strong> n\u00e9cessitent une g\u00e9om\u00e9trie \u00e0 \u201c\u00e9paules arrondies\u201d. Les \u00e9paules pointues concentrent les contraintes. Un \u00e9paulement inclin\u00e9 r\u00e9partit uniform\u00e9ment la carte de pression interne.<\/li>\n\n\n\n<li><strong>Le poids du verre :<\/strong> Vous devez sp\u00e9cifier un moule \u201cHeavy Weight\u201d. Un moule standard de 100 ml <a href=\"https:\/\/glassbottlesupplies.com\/fr\/category\/product\/injection-bottles\/\"   title=\"Flacons pour injection\"  data-wpil-monitor-id=\"799\">flacon injectable<\/a> p\u00e8se environ 85 g. Une bouteille de 100 ml de qualit\u00e9 \u00e9ther devrait peser ~105 g pour fournir l'\u00e9paisseur de paroi n\u00e9cessaire (minimum 2,5 mm) pour contenir la pression de la vapeur.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">La n\u00e9cessit\u00e9 de l'ambre<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">L'\u00e9ther forme des peroxydes explosifs lorsqu'il est expos\u00e9 \u00e0 la lumi\u00e8re UV.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Le Spec :<\/strong> <strong>Verre ambr\u00e9 de type III<\/strong>.<\/li>\n\n\n\n<li><strong>Le pi\u00e8ge :<\/strong> N'achetez pas d'ambre \u201cenrob\u00e9\u201d pour l'\u00e9ther. L'\u00e9ther est un solvant puissant. Si la bouteille est rev\u00eatue ext\u00e9rieurement et qu'une goutte se produit lors du remplissage, l'\u00e9ther d\u00e9capera la peinture, ruinant le lot et supprimant la protection UV. La couleur ambre doit \u00eatre \u201cfondue\u201d (ambre au four).<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Compatibilit\u00e9 de la st\u00e9rilisation : Autoclave ou chaleur s\u00e8che<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Diff\u00e9rents <strong>injection de bouteilles<\/strong> utilisent des m\u00e9thodes de st\u00e9rilisation diff\u00e9rentes. Le verre doit correspondre \u00e0 la m\u00e9thode.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Tunnels de d\u00e9pyrog\u00e9nation (chaleur s\u00e8che)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Temp :<\/strong> 300\u00b0C - 350\u00b0C.<\/li>\n\n\n\n<li><strong>Risque :<\/strong> <strong>Choc thermique<\/strong>.<\/li>\n\n\n\n<li><strong>L'\u00e9chec :<\/strong> Si le <strong>flacon en verre pour injection<\/strong> Si l'\u00e9paisseur de la paroi est in\u00e9gale (par exemple, un fond \u00e9pais et une paroi mince), la partie \u00e9paisse se dilate plus lentement que la partie mince. La bouteille se casse au niveau du \u201ctalon\u201d (coin inf\u00e9rieur).<\/li>\n\n\n\n<li><strong>La solution :<\/strong> Recherche de bouteilles dot\u00e9es de la technologie \u201cUniform Wall Distribution\u201d. Demandez les donn\u00e9es relatives \u00e0 la \u201cvariation de l'\u00e9paisseur de la paroi\u201d. L'\u00e9cart doit \u00eatre inf\u00e9rieur \u00e0 0,2 mm.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Irradiation gamma<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Risque :<\/strong> <strong>D\u00e9coloration<\/strong>.<\/li>\n\n\n\n<li><strong>Le ph\u00e9nom\u00e8ne :<\/strong> Les rayonnements de haute \u00e9nergie font sortir les \u00e9lectrons du r\u00e9seau atomique, cr\u00e9ant ainsi des \u201ccentres de couleur\u201d. Le verre borosilicat\u00e9 transparent devient jaune ou brun (solarisation) apr\u00e8s une st\u00e9rilisation aux rayons gamma.<\/li>\n\n\n\n<li><strong>La solution :<\/strong> Si votre \u00e9tablissement utilise Gamma, vous devez vous procurer <strong>\u201cdop\u00e9 au c\u00e9rium\u201d<\/strong> verre. Le c\u00e9rium agit comme un absorbeur d'\u00e9lectrons, emp\u00eachant le changement de couleur et maintenant la visibilit\u00e9 de l'inspection des liquides claire.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">L'interface Stopper : Lyo vs. Liquid<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Le cou d'un <strong>flacon injectable<\/strong> n'est pas seulement un trou, c'est une station d'accueil pour le bouchon en caoutchouc.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Lyophilisation (lyophilisation)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Si vous produisez des poudres lyophilis\u00e9es :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Le cou :<\/strong> Vous avez besoin d'un <strong>\u201cBlowback\u201d<\/strong> (une rainure \u00e0 l'int\u00e9rieur du manche).<\/li>\n\n\n\n<li><strong>Le processus :<\/strong> Le bouchon reste \u00e0 mi-chemin dans la bouteille pendant le cycle de cong\u00e9lation pour permettre \u00e0 la vapeur d'eau de s'\u00e9chapper. La rainure Blowback saisit les pattes du bouchon, l'emp\u00eachant ainsi de sortir compl\u00e8tement sous l'effet du flux de vapeur.<\/li>\n\n\n\n<li><strong>Le pi\u00e8ge :<\/strong> Si vous achetez un \u201cStraight Wall\u201d (style am\u00e9ricain) <strong>flacon injectable<\/strong> pour une ligne Lyo, les bouchons sauteront des flacons, ruinant la st\u00e9rilit\u00e9 du lot.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Remplissage liquide standard<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Le cou :<\/strong> <strong>\u201cStraight Wall\u201d (mur droit)\u201d<\/strong> (norme ISO).<\/li>\n\n\n\n<li><strong>Pourquoi ?<\/strong> Une rainure Blowback peut pi\u00e9ger du liquide lors d'un remplissage \u00e0 grande vitesse. Ce liquide pi\u00e9g\u00e9 cr\u00e9e un \u201cpont\u201d entre le produit st\u00e9rile et la zone non st\u00e9rile du bouchon, cr\u00e9ant ainsi un vecteur de contamination.<\/li>\n\n\n\n<li><strong>R\u00e8gle :<\/strong> Liquide = paroi droite. Poudre = Retour de flamme.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u00c9tude de cas : La crise de la \u201cd\u00e9rive du pH<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Ce sc\u00e9nario illustre les cons\u00e9quences de l'ignorance de la chimie de surface.<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sujet :<\/strong> <em>Neuro-Solutions Inc.<\/em> (anonyme), fabricant d'un relaxant musculaire g\u00e9n\u00e9rique.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Le contexte :<\/strong> Le m\u00e9dicament a \u00e9t\u00e9 formul\u00e9 \u00e0 un pH de 7,4. La stabilit\u00e9 exigeait qu'il reste entre 7,2 et 7,6. Ils se sont procur\u00e9 10 ml de Clear <strong>bouteilles en verre pour l'injection<\/strong> \u00e9tiquet\u00e9 \u201cverre de type I\u201d en provenance d'une r\u00e9gion \u00e0 faible co\u00fbt afin d'\u00e9conomiser 15% sur les co\u00fbts de production.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>L'incident :<\/strong> Au cours du test de stabilit\u00e9 de 6 mois, le pH de la solution est pass\u00e9 \u00e0 8,1.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>La cons\u00e9quence :<\/strong> L'ingr\u00e9dient actif a commenc\u00e9 \u00e0 se d\u00e9grader en impuret\u00e9s. Le lot n'a pas satisfait aux protocoles de stabilit\u00e9 de la FDA.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>L'analyse m\u00e9dico-l\u00e9gale :<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Le verre :<\/strong> Il s'agissait bien de verre borosilicat\u00e9 (type I).<\/li>\n\n\n\n<li><strong>La fabrication :<\/strong> Les tubes de verre ont \u00e9t\u00e9 form\u00e9s en flacons \u00e0 une chaleur excessive (surchauffe).<\/li>\n\n\n\n<li><strong>Le m\u00e9canisme :<\/strong> La chaleur \u00e9lev\u00e9e a provoqu\u00e9 l'\u00e9vaporation du bore de la surface int\u00e9rieure pendant le formage. Cela a laiss\u00e9 une couche superficielle riche en sodium et pauvre en bore. En effet, le <em>surface<\/em> \u00e9tait de la chaux sod\u00e9e de type II, m\u00eame si les <em>en vrac<\/em> Le verre \u00e9tait de type I.<\/li>\n\n\n\n<li><strong>Le lessivage :<\/strong> Cette couche riche en sodium s'est dissoute dans le m\u00e9dicament, augmentant ainsi le pH.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>La solution :<\/strong> Neuro-Solutions a chang\u00e9 de fournisseur en utilisant <strong>\u201cTraitement au sulfate d'ammonium\u201d<\/strong> sur leurs flacons de type I.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Le processus :<\/strong> Une dose de sulfate d'ammonium est inject\u00e9e dans le flacon imm\u00e9diatement apr\u00e8s la formation. Il absorbe le sodium de surface et neutralise les \u201cdommages caus\u00e9s par la chaleur\u201d.\u201d<\/li>\n\n\n\n<li><strong>Le r\u00e9sultat :<\/strong> Les nouveaux flacons ont pass\u00e9 le test ISO 4802 \u201cSurface Hydrolytic Resistance\u201d avec une valeur 5 fois inf\u00e9rieure \u00e0 celle du lot d\u00e9fectueux. Le pH est rest\u00e9 stable \u00e0 7,4.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">2026 Normes d'inspection : Cosm\u00e9tique ou critique<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Lors de l'achat <strong>injection de bouteilles<\/strong> le conditionnement, la limite de qualit\u00e9 acceptable (LQA) doit \u00eatre d\u00e9finie dans le contrat.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Air Lines (Compagnies a\u00e9riennes)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Quoi ?<\/strong> Bulles fines et allong\u00e9es dans la paroi du verre.<\/li>\n\n\n\n<li><strong>Criticit\u00e9 :<\/strong> Dans un flacon standard, il s'agit d'un produit cosm\u00e9tique. Dans un <strong>flacon d'injection d'\u00e9ther<\/strong> (sous pression), il s'agit d'un point faible structurel.<\/li>\n\n\n\n<li><strong>Spec :<\/strong> \u201cAucune ligne a\u00e9rienne d'une longueur sup\u00e9rieure \u00e0 5 mm n'est autoris\u00e9e dans le corps. Aucune ligne a\u00e9rienne n'est autoris\u00e9e dans le cou.\u201d<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Fissures de contr\u00f4le (Crizzling)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Quoi ?<\/strong> Fissures superficielles microscopiques, ressemblant souvent \u00e0 de la poussi\u00e8re scintillante.<\/li>\n\n\n\n<li><strong>Criticit\u00e9 :<\/strong> Critique. Il s'agit de fractures sous contrainte. Elles se propagent sous l'effet de la chaleur de la st\u00e9rilisation.<\/li>\n\n\n\n<li><strong>D\u00e9tection :<\/strong> N\u00e9cessite une \u201cinspection par cam\u00e9ra \u00e0 grande vitesse\u201d \u00e0 l'usine. L'\u0153il humain ne peut pas d\u00e9tecter le crizzling \u00e0 des vitesses de production \u00e9lev\u00e9es.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La s\u00e9lection d'un <strong>flacon en verre pour injection<\/strong> est une d\u00e9cision qui d\u00e9termine la dur\u00e9e de conservation et la s\u00e9curit\u00e9 du produit pharmaceutique. Il s'agit d'une n\u00e9gociation avec la chimie.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pour <strong>Flacons d'injection d'\u00e9ther<\/strong>, La priorit\u00e9 est donn\u00e9e \u00e0 la r\u00e9sistance \u00e0 l'\u00e9clatement et \u00e0 la protection contre les UV. Pour les produits biologiques <strong>flacons injectables<\/strong>, La priorit\u00e9 est donn\u00e9e \u00e0 l'alcalinit\u00e9 de la surface et \u00e0 la r\u00e9sistance \u00e0 l'hydrolyse.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En 2026, le co\u00fbt du verre est insignifiant par rapport \u00e0 la valeur du m\u00e9dicament qu'il contient. Une strat\u00e9gie d'approvisionnement digne de ce nom donne la priorit\u00e9 au verre de \u201ctype I Expansion 33\u201d et exige du fournisseur des \u201cdonn\u00e9es hydrolytiques de surface\u201d pour s'assurer que le r\u00e9cipient reste un partenaire silencieux et inerte dans le processus de gu\u00e9rison, plut\u00f4t qu'un contaminant chimiquement actif.<\/p>","protected":false},"excerpt":{"rendered":"<p>In the pharmaceutical supply chain, the glass bottle for injection is the only component that faces the most extreme thermal and chemical stress before it ever meets the drug. It is washed at 80\u00b0C, depyrogenated at 300\u00b0C, and often autoclaved at 121\u00b0C. 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It is washed at 80\u00b0C, depyrogenated at 300\u00b0C, and often autoclaved at 121\u00b0C. For B2B buyers and quality engineers, the risk is not just breakage; it","og:url":"https:\/\/glassbottlesupplies.com\/fr\/2026-sterilization-protocol-managing-alkalinity-shift-and-thermal-shock-in-glass-bottles-for-injection\/","article:published_time":"2026-01-13T09:27:36+00:00","article:modified_time":"2026-01-04T09:28:58+00:00","twitter:card":"summary_large_image","twitter:title":"2026 Sterilization Protocol: Managing Alkalinity Shift and Thermal Shock in Glass Bottles for Injection - GlassBottleSupplies","twitter:description":"In the pharmaceutical supply chain, the glass bottle for injection is the only component that faces the most extreme thermal and chemical stress before it ever meets the drug. It is washed at 80\u00b0C, depyrogenated at 300\u00b0C, and often autoclaved at 121\u00b0C. 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