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Indena | 製造施設
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href="https://www.indena.com/ja/">ホームページ</a></li> <li>イノベーション</li> <li>製造施設</li></ul></nav> </div> <div class="text-zone" data-aos="fade-up" data-aos-duration="1000"> <p class="pre-title">イノベーション</p> <div class="text-row"> <div class="left"> <h2>製造施設</h2> </div> <div class="right"> <p>Our manufacturing facilities –<strong> Indena’s hidden heart of steel – are a powerful, complex technological ecosystem that stands out worldwide for unparalleled care for detail and painstaking maintenance.<br><br></strong>Created so our phytochemical culture could provide solutions for people’s health and wellbeing, this infrastructure physically expresses our deepest values: visitors in Settala – and in all Indena production sites – always leave with a sense of our boldness, quality, safety and reliability, thanks to the perfect integration of technological power, functional aspects and aesthetic features.<br><br><strong>By definition, industrial plants prioritize function over form. Yet ours were designed with bright steel, symmetrical patterns and textures – to reveal the surprising beauty of our industry and science.<br><br></strong>We devote great effort and resources <span>to ensuring good manufacturing practices, safety and sustainability in its facilities and production plants.</span><br><br><span>This is why the company counts numerous certifications.<br><br></span><span>Our facilities in Milano, Settala, Palestro and Tours are certified GMP, ISO 14001, ISO 45001, AEO validated and FDA Food Facility registered. Facilities in Settala, Palestro and Tours are also certified Kosher and Halal. Facilities in Milan, Settala and Palestro are certified ISO 22000. Facilities in Milan and Settala are C-TPAT validated. Finally, our facility in Tours is also FSSC 22000 certified and the one in India is GMP certified.</span></p> </div> </div> </div> </div> </section> <section id="part_1" class="gallery white" data-bg="white" > <div class="gallery-wrapper"> <div class="gallery-content"> <div class="swiper-container"> <div class="swiper-wrapper"> <div class="swiper-slide gallery-slide"> <div class="img-wrapper"> <div class="padding-ratio"> <img class="fill lazy" data-src="https://www.indena.com/indena_files/2020/12/gallery-1MM.jpg" alt=""> <div class="img-loader"></div> </div> </div> </div> <div class="swiper-slide gallery-slide"> <div class="img-wrapper"> <div class="padding-ratio"> <img class="fill lazy" data-src="https://www.indena.com/indena_files/2020/12/gallery-2MM.jpg" alt=""> <div class="img-loader"></div> </div> </div> </div> <div class="swiper-slide gallery-slide"> <div class="img-wrapper"> <div class="padding-ratio"> <img class="fill lazy" 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<h2><strong>Plants for Plants® (植物のための工場)</strong></h2> </div> <div class="right"> <p><strong>インデナの天然植物誘導体の抽出、単離および精製のための製造および科学研究サービスには、医薬品および食品グレードの成分の幅広い製造能力が含まれています</strong>。当社の専門知識と最先端の設備を組み合わせることで、小規模な注文から大規模な商業製造供給までの製品およびプロセスを提供することが可能になります。</p> </div> </div> </div> </div> </section> <section id="part_4" class="banner-download padding-bottom offset-left offset-right white" data-bg="white" > <div class="banner-download-wrapper"> <div class="container-fluid"> <div class="row"> <div class="col-12 col-md-3 image-wrapper"> <img src="https://www.indena.com/indena_files/2021/01/catalogo-generico.png" alt="Plants for Plants® (植物のための工場)"> </div> <div class="col-12 col-md-9 col-lg-8 content-wrapper"> <div class="content"> <div class="text" data-aos="fade-up" data-aos-duration="1000"> <h2>Plants for Plants® (植物のための工場)</h2> </div> <div class="cta"> <div class="btn-wrapper" data-aos="fade-up" data-aos-duration="1000"> <div class="wd-button-wrapper"> <a id="open-filebanner-4-1" role="link" class="wd-button primary" href="https://www.indena.com/indena_files/2020/12/plants_for_plants_capabilities.pdf" target="_blank"> <span class="button-label">ダウンロード</span> <svg class="icon"><use xlink:href="https://www.indena.com/indena_theme/assets/svg/wd-sprite.svg#wd-download"></use></svg> </a> </div> </div> </div> </div> </div> </div> </div> </div> </section> <section id="part_5" class="img-responsive-section padding-bottom offset-left offset-right white" data-bg="white" > <div class="img-responsive-section-wrapper"> <div class="img-wrapper"> <div class="padding-ratio "> <picture class="img-fill"> <img class="lazy fill" data-src="https://www.indena.com/indena_files/2020/12/plants-for-plantsMM.jpg" alt="plants-for-plants"> <div class="img-loader"></div> </picture> </div> </div> </div> </section> <div id="part_6" class="h2-anchor-wrapper padding-bottom offset-left offset-right" data-bg="white"> <h2 class="js-anchor" id="section_6">イノベーション</h2> </div> <section id="part_7" class="complete-text-block offset-left offset-right white " data-bg="white" > <div class="complete-text-block-wrapper"> <div class="text-zone" data-aos="fade-up" data-aos-duration="1000"> <p class="pre-title">イノベーション</p> <div class="text-row"> <div class="left"> <h2><strong>柔軟性を大切にする </strong></h2> </div> <div class="right"> <p>cGMPの適用と世界中の保健当局による監督により、当社のアプローチは確固たる質の高さを誇っており、インデナは常にコストと時間がせめぎあう中、賢明なバランスを維持してきました。</p> <p><strong>このような状況において、柔軟性はそれ自体が強みであり価値あるものとなっています。</strong> 使い捨てのシステムであれ、連続生産であれ、モジュール設計であれ、新しいテクノロジーを採用し、そして適応することは、敏捷性の優先度が非常に高い今日の現実において極めて重要です。これは、天然誘導体の分野以外にも、開発中の新規プロジェクトから新規製造施設に至るまで、幅広い応用分野で見られます。</p> <p> </p> <p> </p> </div> </div> </div> </div> </section> <section id="part_8" class="text-image-block offset-left offset-right white " data-bg="white" > <div class="text-image-block-wrapper"> <div class="text positive"> <div class="text-content" data-aos="fade-up" data-aos-duration="1000"> <h3>終わることのないイノベーション</h3> <p>当社は、医薬品、健康食品およびパーソナルケア業界で使用する植物由来の有効成分を発見、開発および生産する世界有数の企業です。それでも当社は毎年、当社の提案をさらに拡張するために革新的なテクノロジーとサービスに投資を続けています。<br /> <br /> <b>インデナの施設には、医薬品および食品グレードの天然誘導体の取り扱いが承認されている分離されたエリアが含まれており、当社の品質システムはcGMPと危害分析重要管理点（HACCP）ガイドラインともに確実に遵守しています。</b></p> <a id="cta-textmedia-8" role="link" class="simple-cta" href="/ja/innovation/quality/" target="_self"> <span class="label">当社の品質について知る</span><svg class="icon sm"><use xlink:href="https://www.indena.com/indena_theme/assets/svg/wd-sprite.svg#wd-arrow-r"></use></svg> </a> </div> </div> <div class="image"> <div class="image-wrapper"> <img class="lazy" data-src="https://www.indena.com/indena_files/2020/12/endless-innovationMM-1.jpg" alt="終わることのないイノベーション"> <div class="img-loader"></div> </div> </div> </div> </section> <div id="part_9" class="h2-anchor-wrapper padding-top padding-bottom offset-left offset-right" data-bg="white"> <h2 class="js-anchor" id="section_9">設備</h2> </div> <section id="part_10" class="text-image-block offset-left offset-right white specular " data-bg="white" > <div class="text-image-block-wrapper"> <div class="text positive"> <div class="text-content" data-aos="fade-up" data-aos-duration="1000"> <h3>当社の工場設備 </h3> <p>機器に関しては、長年にわたりインデナは、新しいHPAPI（高生理活性の医薬品原薬)のキロラボ、パイロット医薬品工場およびPSD2モデルのスプレードライヤー（噴霧乾燥機）など、革新的な設備群をセッターラ（イタリア・ミラノ）にある当社の主要製造拠点で開発してきました。さらに、当社の発酵プラントを多目的用途にアップグレードしました。<br /> <br /> インデナの製造拠点には、本来は職業暴露限界（OEL）が800 ng/m3の半合成のHPAPIを年間数百キロ生産するよう設計された大規模アイソレータがすでに装備されていました。これらは現在、より毒性の高い（天然および合成）化合物を取り扱うために改良されており、OELがわずか150 ng/m3の化合物を扱える設備となっています。この大規模な設備群は、OELが20 ng/m3の非常に効力の強い化合物を集中的に扱う真新しいキロラボ（既存のLK1ラインに加えLK2ライン）を開設することで補完されてきました。<br /> </p> </div> </div> <div class="image"> <div class="image-wrapper"> <img class="lazy" data-src="https://www.indena.com/indena_files/2020/12/our-plant-equipmentMM.jpg" alt="当社の工場設備 "> <div class="img-loader"></div> </div> </div> </div> </section> <section id="part_11" class="text-image-block offset-left offset-right white " data-bg="white" > <div class="text-image-block-wrapper"> <div class="text positive"> <div class="text-content" data-aos="fade-up" data-aos-duration="1000"> <h3>新しい医薬品パイロットプラント</h3> <p><p>さらにインデナは、規模や運用条件の点で、薬理活性の低い化合物の製造のために、高い柔軟性を持つ、真新しいパイロット設備群を開設しました。これ付随して、臨床用バッチのGMP製造、薬理活性の低い弱い中間体の製造および数十キロの範囲で年間生産量が必要な商業バッチに適した医薬品パイロットプラントを設置しました。</p></p> </div> </div> <div class="image"> <div class="image-wrapper"> <img class="lazy" data-src="https://www.indena.com/indena_files/2020/12/the-new-pilot-pharmaceuticals-plantV.jpg" alt="新しい医薬品パイロットプラント"> <div class="img-loader"></div> </div> </div> </div> </section> <section id="part_12" class="text-image-block offset-left offset-right white specular " data-bg="white" > <div class="text-image-block-wrapper"> <div class="text positive"> <div class="text-content" data-aos="fade-up" data-aos-duration="1000"> <h3>新しいGEA社製 PSD2のスプレードライヤー</h3> <p><p>さらに、すでに数年にわたって実施してきた技術的な設備投資のここ数年間の延長として、当社ではGea社製の PSD2モデルのスプレードライヤーを設置し、1990年代前半まで有機溶媒で動かしていた大規模なスプレードライヤーに加えて追加導入しました。PSD2モデルは中型の臨床用および商業用機器で、クラス2の有機溶媒を取り扱うことができ、OELが10 μg/m3以上のAPIおよび事前に製剤化されているAPI（製剤中間体に分類される添加剤がある場合に噴霧乾燥を使用）の生産を実施するよう設計されています。<br /> .<br></p></p> </div> </div> <div class="image"> <div class="image-wrapper"> <img class="lazy" data-src="https://www.indena.com/indena_files/2021/01/the-new-gea-psd2-dpray-dryer-lg.jpg" alt="新しいGEA社製 PSD2のスプレードライヤー"> <div class="img-loader"></div> </div> </div> </div> </section> <section id="part_13" class="text-image-block padding-bottom offset-left offset-right white " data-bg="white" > <div class="text-image-block-wrapper"> <div class="text positive"> <div class="text-content" data-aos="fade-up" data-aos-duration="1000"> <h3>多目的発酵プラント</h3> <p><p>T顧客へのサービスの改善と向上を目指し、この計画を完了するために、当社は（独自の化合物の生物学的変換に特化した）既存の発酵プラントを改良し、多目的化を図りました。<br /> <br /> このプラントには、1,000リットルから20,000リットルまでの容量を持つ工業用機器が搭載されており、10リットルの研究室の発酵槽ならびに100リットルと150リットルのパイロットスケールの発酵槽が備えられています。際立った特徴としては、荒野化売り活性の化合物を発酵させる能力があることです。そのため、製造の下流工程が行われる既存の高薬理活性原薬の設備群と十分に統合されています。</p></p> </div> </div> <div class="image"> <div class="image-wrapper"> <img class="lazy" data-src="https://www.indena.com/indena_files/2020/12/a-mulripurpose-fermetation.-planTMM-2.jpg" alt="多目的発酵プラント"> <div class="img-loader"></div> </div> </div> </div> </section> <section id="part_16" class="text-image-block offset-left offset-right white " data-bg="white" > <div class="text-image-block-wrapper"> <div class="text negative"> <div class="text-content" data-aos="fade-up" data-aos-duration="1000"> <h3>Indenaの研究開発を注視する</h3> <p>自然は、素晴らしいアイデアへの限りないインスピレーションを与えてくれます。当社の研究開発部門は、人類が自然界の指標を受け入れながら、自分の健康をどのように管理するかを探る手段として、ファイトケミカル工学に特化した社内シンクタンクです。</p> <a id="cta-textmedia-16" role="link" class="simple-cta" href="/ja/innovation/rd/" target="_self"> <span class="label">もっと見る</span><svg class="icon sm"><use 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