{"id":811,"date":"2025-06-26T03:09:02","date_gmt":"2025-06-26T03:09:02","guid":{"rendered":"https:\/\/amidef-ri.com\/?page_id=811"},"modified":"2025-09-01T06:09:43","modified_gmt":"2025-09-01T06:09:43","slug":"design-dan-pemasangan-clean-room","status":"publish","type":"page","link":"https:\/\/amidef-ri.com\/en\/design-dan-pemasangan-clean-room\/","title":{"rendered":"Design dan Pemasangan Clean Room"},"content":{"rendered":"
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Home<\/a><\/span><\/span><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Nama Layanan :<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Design dan Pemasangan Clean Room<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Clean room atau ruang bersih adalah\u00a0ruangan khusus yang dirancang untuk lingkungan yang sangat terkontrol dan minim kontaminasi partikel, mikroorganisme, dan partikel udara lainnya, seperti debu dan aerosol<\/mark>.\u00a0<\/span>Ruangan ini sangat penting dalam industri seperti farmasi, elektronik, dan bioteknologi untuk memastikan kualitas produk dan integritas penelitian dengan mengendalikan tingkat kebersihan sesuai standar internasional, misalnya standar ISO<\/span><\/p>

Desain Cleanroom<\/h3>

Desain cleanroom bertujuan untuk menciptakan ruang dengan kualitas udara, tekanan, dan kebersihan tertentu agar proses produksi farmasi aman dari kontaminasi.<\/p>

– Tahap Desain Awal<\/h6>

  • Analisis kebutuhan : menentukan klasifikasi ruangan (ISO 5\u2013ISO 8 atau Grade A\u2013D sesuai CPOB\/GMP).<\/p><\/li>

  • Studi alur kerja : memisahkan alur material, personel, dan limbah untuk mencegah kontaminasi silang.<\/p><\/li>

  • Tata letak (layout) : mengatur ruang produksi, ruang penyangga (airlock), ruang teknis, dan ruang pendukung lainnya.<\/p><\/li><\/ul>

    – Elemen Desain Utama<\/h6>

    1. Struktur Dinding & Plafon<\/p>

      • Menggunakan panel sandwich panel (EPS, PU, atau rockwool) dengan permukaan halus, tahan kimia, dan mudah dibersihkan.<\/p><\/li><\/ul><\/li>

      • Lantai Cleanroom<\/p>

        • Lantai epoxy atau vinyl antistatik untuk mencegah debu menempel.<\/p><\/li><\/ul><\/li>

        • Pintu & Jendela<\/p>

          • Pintu interlock dengan sistem kontrol untuk menjaga tekanan udara.<\/p><\/li>

          • Jendela flush dengan permukaan rata untuk mencegah area penumpukan debu.<\/p><\/li><\/ul><\/li>

          • HVAC & HEPA Filter<\/p>

            • Sistem HVAC menjaga tekanan, suhu, dan kelembaban stabil.<\/p><\/li>

            • HEPA filter dipasang di titik supply udara untuk menjamin kualitas udara sesuai standar.<\/p><\/li><\/ul><\/li>

            • Tekanan Diferensial<\/p>

              • Positive pressure di ruang kritis untuk mencegah masuknya partikel.<\/p><\/li><\/ul><\/li>

              • Lighting & Elektrikal<\/p>

                • Lampu LED dengan intensitas sesuai standar kebersihan dan mudah dibersihkan.<\/p><\/li><\/ul><\/li><\/ol>

                  – Dokumen Desain<\/h6>

                  • Layout 2D & 3D cleanroom.<\/p><\/li>

                  • User Requirement Specification (URS).<\/p><\/li>

                  • P&ID (Piping and Instrumentation Diagram) untuk sistem pendukung.

                    <\/p><\/li><\/ul>

                    Pemasangan Cleanroom<\/strong><\/h3>

                    Setelah desain disetujui, dilakukan tahap instalasi:<\/p>

                    – Pekerjaan Sipil & Persiapan<\/h6>

                    • Pembersihan area kerja dan pemasangan kerangka struktur untuk dinding, plafon, dan lantai.<\/p><\/li>

                    • Pemasangan jalur utilitas (listrik, HVAC, pipa air, gas, dan automasi).<\/p><\/li><\/ul>

                      – Pemasangan Dinding & Plafon<\/h6>

                      • Pemasangan panel dinding sesuai layout dengan sambungan silicon sealant untuk mencegah kebocoran udara.<\/p><\/li>

                      • Plafon cleanroom dipasang untuk menahan HEPA filter, lampu, dan diffuser udara.<\/p><\/li><\/ul>

                        – Instalasi Lantai & Aksesori<\/h6>

                        • Lantai epoxy\/vinyl dipasang dengan sambungan minim untuk mencegah penumpukan kotoran.<\/p><\/li>

                        • Pemasangan pintu interlock, passbox, dan jendela flush sesuai desain.<\/p><\/li><\/ul>

                          – Pemasangan HVAC & Sistem Kontrol<\/h6>

                          • Integrasi HEPA filter, ducting, dan AHU untuk menjaga kualitas udara.<\/p><\/li>

                          • Sistem monitoring suhu, kelembaban, dan tekanan udara dihubungkan ke SCADA\/BMS.

                            <\/p><\/li><\/ul>

                            Uji Kualifikasi & Validasi<\/h3>

                            Sebelum cleanroom digunakan, dilakukan:<\/p>

                            • Installation Qualification (IQ) :<\/strong> memverifikasi pemasangan sesuai desain.<\/p><\/li>

                            • Operational Qualification (OQ) :<\/strong> memastikan semua sistem berfungsi dengan benar.<\/p><\/li>

                            • Performance Qualification (PQ) :<\/strong> menguji kondisi aktual saat operasi.<\/p><\/li><\/ul>

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                              Layanan Yang Diberikan :<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                              \n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDESIGN\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

                              \n\t\t\t\t\t\tKami menciptakan fasilitas yang aman, efisien, dan memenuhi regulasi sebelum masuk ke tahap pembangunan dan operasional.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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                              \n\t\t\t\t\t\t\n\t\t\t\t\t\t\tEXECUTION\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

                              \n\t\t\t\t\t\tMewujudkan desain menjadi fasilitas yang siap operasi dengan kualitas, keamanan, dan kepatuhan standar yang terjamin.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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                              \n\t\t\t\t\t\t\n\t\t\t\t\t\t\t PENDAMPINGAN BPOM\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

                              \n\t\t\t\t\t\tAgar fasilitas lulus inspeksi BPOM dengan lancar dan mendapatkan sertifikasi yang diperlukan untuk beroperasi.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t

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                              <\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

                              Nama Layanan : Design dan Pemasangan Clean Room Clean room atau ruang bersih adalah\u00a0ruangan khusus yang dirancang untuk lingkungan yang […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-811","page","type-page","status-publish","hentry"],"yoast_head":"\nDesign dan Pemasangan Clean Room - 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