[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"site-settings":3,"blog-kualifikasi-cleanroom-farmasi-iq-oq-pq-panduan-2026--":40,"header-product-categories":83,"footer-product-categories":242,"blog-recent":280},{"data":4},{"business_hours":5,"canonical_url":6,"catalog_full_url":7,"catalog_price_url":7,"catalog_technical_url":7,"contact_address":8,"contact_email":9,"contact_factory_address":10,"contact_factory_map_url":11,"contact_office_address":7,"contact_phone":12,"contact_whatsapp":13,"custom_body_scripts":7,"custom_head_scripts":14,"ga_measurement_id":15,"google_ads_id":16,"gtm_id":17,"homepage_meta_description_en":18,"homepage_meta_description_id":19,"homepage_meta_description_zh":20,"homepage_meta_title_en":21,"homepage_meta_title_id":22,"homepage_meta_title_zh":23,"maintenance_message":7,"maintenance_mode":24,"meta_description_default":25,"meta_title_default":26,"og_image_default":27,"recaptcha_site_key":7,"robots_txt":28,"schema_org_founded":29,"schema_org_type":30,"seo_noindex":24,"site_email":9,"site_favicon_url":31,"site_logo_url":32,"site_name":33,"site_stats":34,"site_tagline":35,"social_facebook":36,"social_instagram":37,"social_linkedin":7,"social_youtube":38,"whatsapp_message":39,"whatsapp_number":12},"Senin-Sabtu 08:00-17:00 WIB","https://sandwichpanels.id","","Jakarta, Indonesia","marketing@sandwichpanels.id","Kawasan Industri Lippo Cikarang Delta Silicon, Jl. Albasia Utara 1, Cikarang Selatan, Jawa Barat, Indonesia, 17550","https://maps.google.com/?q=-6.3666492909764205, 107.12342048001176","+628119898835","628119898835","\u003Cmeta name=\"google-site-verification\" content=\"tjwEbF9G67SnEcroXL7PBzxRcLoD0NaRxKXRgRvOV6o\" />","G-DPYQT7JZ2D","G-ETSSTN3J3T","GTM-5XRVSZWC","SandwichPanels.id supplies EPS, PU, PIR, and rockwool sandwich panels for factories, cold rooms, cleanrooms, and industrial buildings in Indonesia.","SandwichPanels.id menyediakan sandwich panel EPS, PU, PIR, dan rockwool untuk pabrik, cold storage, cleanroom, dan bangunan industri di Indonesia.","SandwichPanels.id 为印度尼西亚工厂、冷库、洁净室与工业建筑提供 EPS、PU、PIR 和岩棉夹芯板解决方案。","Sandwich Panels Indonesia for Cold Rooms and Factories","Sandwich Panel Indonesia untuk Pabrik, Cold Room, Cleanroom","印度尼西亚工厂、冷库与洁净室夹芯板","false","Supplier sandwich panel EPS, PU, PIR, dan rockwool untuk pabrik, cold storage, cleanroom, dan bangunan industri di Indonesia.","Sandwich Panel Indonesia untuk Pabrik & Cold Room","https://sandwichpanels.id/og-image.jpg","# SandwichPanels.id - Robots.txt\n# https://sandwichpanels.id\n\nUser-agent: *\nAllow: /\nDisallow: /api/\nDisallow: /*?utm_*\n\n# Sitemaps\nSitemap: https://sandwichpanels.id/sitemap_index.xml\n\n# AI Crawlers — welcome to index our public content\nUser-agent: GPTBot\nAllow: /\nCrawl-delay: 2\n\nUser-agent: ChatGPT-User\nAllow: /\n\nUser-agent: Google-Extended\nAllow: /\n\nUser-agent: Googlebot\nAllow: /\n\nUser-agent: PerplexityBot\nAllow: /\nCrawl-delay: 2\n\nUser-agent: ClaudeBot\nAllow: /\nCrawl-delay: 2\n\nUser-agent: Bytespider\nAllow: /\nCrawl-delay: 5\n\nUser-agent: CCBot\nAllow: /\nCrawl-delay: 5\n\nUser-agent: Applebot-Extended\nAllow: /\n\nUser-agent: cohere-ai\nAllow: /\nCrawl-delay: 2\n\n# Crawl-delay for SEO tools\nUser-agent: AhrefsBot\nCrawl-delay: 10\n\nUser-agent: SemrushBot\nCrawl-delay: 10\n\n# Block known bad / scraper bots\nUser-agent: DotBot\nDisallow: /\n\nUser-agent: MJ12bot\nDisallow: /\n\nUser-agent: AdsBot-Google\nAllow: /\n","2001","LocalBusiness","https://assets.sandwichpanels.id/uploads/1771832459130-favicon-tiny.png","https://assets.sandwichpanels.id/branding/logo-main-transparent.png","SandwichPanels.id","{\"projects\":\"1000\",\"clients\":\"1000\",\"experience\":\"25\",\"area\":\"1000000\",\"cities\":\"\"}","Distributor dan produsen produk Sandwich panel berkualitas internasional.","https://facebook.com/cleanroomindonesia/","https://www.instagram.com/cleanroomindonesia/","https://youtube.com/@CleanroomIndonesia","Halo, saya ingin bertanya mengenai produk Sandwich panel...",{"author_name":41,"category":42,"content":48,"cover_image":52,"created_at":53,"excerpt":54,"id":58,"published":59,"published_at":60,"seo":61,"slug":70,"tags":71,"title":79,"updated_at":60},"Administrator",{"name":43,"slug":47},{"en":44,"id":45,"zh":46},"Guides & Tutorials","Panduan & Tutorial","指南与教程","panduan",{"en":49,"id":50,"zh":51},"\u003Cp>Cleanroom qualification is the documented process of proving that a clean space genuinely operates as designed and sustains the required cleanliness class throughout the production cycle. For pharmaceutical plants, medical device makers, and sterile food processors in Indonesia, this is far more than paperwork — a failed qualification means the facility cannot legally operate until the deviation is fixed and retested by an independent assessor.\u003C/p>\u003Cp>A question project owners often ask: why do two cleanrooms with near-identical HVAC specifications end up with different qualification outcomes? The answer usually sits in details rarely covered elsewhere — wall panel joint quality, instrument calibration, or a test sequence that skips a mandatory step. This article summarizes the DQ-IQ-OQ-PQ stages, the critical test parameters, the requalification schedule under \u003Ca href=\"https://www.iso.org/standard/53394.html\" target=\"_blank\" rel=\"noopener\">ISO 14644-1:2015\u003C/a> and EU GMP Annex 1, and how wall material choice ties into passing certification.\u003C/p>\u003Ch2>What Is Cleanroom Qualification and Why Is It Mandatory?\u003C/h2>\u003Cp>Cleanroom qualification (also called clean space validation) is a set of tests proving that the HVAC system, HEPA filters, and building envelope actually achieve the planned air cleanliness class — not merely a claim on a design brochure. In Indonesia, this is a mandatory part of Cara Pembuatan Obat yang Baik (CPOB) certification overseen by BPOM for pharmaceutical manufacturers, and an implicit requirement for food GMP and medical device certification.\u003C/p>\u003Cp>Without documented qualification, a clean space is only an \"air-conditioned room with a filter,\" not a certified cleanroom. BPOM auditors and international inspectors (FDA, EU GMP inspectors for export products) will ask for DQ, IQ, OQ, and PQ documentation as the primary evidence before a facility is cleared for commercial production.\u003C/p>\u003Ch2>The DQ, IQ, OQ, and PQ Stages of Cleanroom Qualification\u003C/h2>\u003Cp>Cleanroom qualification follows a fixed sequence that cannot be skipped, since each stage is a documented prerequisite for the next:\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>Design Qualification (DQ)\u003C/strong> — verifies that layout drawings, wall/ceiling material choices, room adjacency, and HVAC specifications match process needs and regulatory requirements before construction even begins.\u003C/li>\u003Cli>\u003Cstrong>Installation Qualification (IQ)\u003C/strong> — confirms every component (AHU unit, HEPA filters, pressure/temperature sensors, UV lamps, wall panels, interlocked doors) is installed per the design spec, backed by instrument calibration certificates.\u003C/li>\u003Cli>\u003Cstrong>Operational Qualification (OQ)\u003C/strong> — tests whether the system runs within set limits under an \"as built,\" unoccupied state: airflow velocity, air change rate (ACH), differential pressure between rooms, HEPA filter leak testing, and at-rest particle counts.\u003C/li>\u003Cli>\u003Cstrong>Performance Qualification (PQ)\u003C/strong> — proves the cleanroom still meets its cleanliness class while fully operating with personnel and production equipment running (in-operation state), including viable and non-viable microbial monitoring.\u003C/li>\u003C/ul>\u003Cp>Indonesian pharmaceutical facilities typically need 3 to 6 months to complete all four stages after construction finishes, depending on facility complexity and how ready the company's internal validation protocols are.\u003C/p>\u003Cimg src=\"https://assets.sandwichpanels.id/blog/1785442474294-kualifikasi-cleanroom-hepa-filter-leak-test-inline-01.png\" alt=\"Technician testing air particle counts and differential pressure inside a pharmaceutical cleanroom built with sandwich panel walls\" />\u003Ch2>Critical Test Parameters: Particles, ACH, Pressure, and Filter Leaks\u003C/h2>\u003Cp>The following parameters are usually the auditor's main focus when reviewing OQ and PQ reports:\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>Airborne particle counts\u003C/strong> — measured with a particle counter per ISO 14644-1 and compared against ISO class limits (ISO 5 roughly equals EU GMP Grade A/B).\u003C/li>\u003Cli>\u003Cstrong>Air Change Rate (ACH)\u003C/strong> — the number of air changes per hour, ensuring particles and contaminants dilute as fast as the DQ stage planned.\u003C/li>\u003Cli>\u003Cstrong>Differential pressure\u003C/strong> — maintains airflow direction from cleaner to less-clean zones so contaminants cannot migrate backward.\u003C/li>\u003Cli>\u003Cstrong>HEPA filter leak testing\u003C/strong> — uses an aerosol photometer to confirm no leaks exist in the filter media or frame seals, following ISO 14644-3 methodology.\u003C/li>\u003Cli>\u003Cstrong>Smoke visualization studies\u003C/strong> — specifically for unidirectional/laminar Grade A zones, proving the airflow pattern truly runs one-way without turbulence at critical points.\u003C/li>\u003Cli>\u003Cstrong>Viable microbial monitoring\u003C/strong> — settle plates, contact plates, and active air sampling, with the strictest limits in Grade A (no colony growth allowed on a contact plate) and Grade B (maximum 5 CFU per plate).\u003C/li>\u003C/ul>\u003Ch2>Requalification Frequency Under ISO 14644-2 and EU GMP Annex 1\u003C/h2>\u003Cp>The ISO 14644-2:2015 revision removed the fixed schedule table from the earlier edition, requiring every facility to build its own risk-based requalification schedule. Even so, EU GMP Annex 1 (2022 revision) still offers a practical benchmark widely adopted across the industry: requalify at least every 6 months for Grade A and B, and every 12 months for Grade C and D.\u003C/p>\u003Cp>Additional requalification is mandatory whenever a significant change occurs — HEPA filter replacement, HVAC ducting modification, wall or ceiling renovation, or a change in production equipment layout. Relying on an old certificate after such changes is one of the most common causes of failed BPOM audits and export inspections.\u003C/p>\u003Ch2>How Sandwich Panel Wall Material Affects Qualification Outcomes\u003C/h2>\u003Cp>Many IQ and OQ failures actually originate from the room envelope material and its installation, not the HVAC system itself. Loose panel joints, shrinking sealant, or a wall-to-floor junction without a curved coving will leak air and become a particle accumulation point — exactly what our article on \u003Ca href=\"https://sandwichpanels.id/en/blog/kesalahan-material-dinding-cleanroom-gagal-sertifikasi-2026\" target=\"_blank\" rel=\"noopener\">cleanroom wall material mistakes that cause certification failure\u003C/a> explains in detail.\u003C/p>\u003Cp>PU/PIR-core sandwich panels with pre-painted galvanized steel facing and precision tongue-and-groove joints help preserve differential pressure integrity during OQ, since air leakage between rooms is far lower than with conventional gypsum-partitioned or plastered brick walls. Our full guide to cleanliness classes and how they relate to building specification choices is available in the \u003Ca href=\"https://sandwichpanels.id/en/blog/klasifikasi-cleanroom-iso-14644-panduan-kelas-standar-2026\" target=\"_blank\" rel=\"noopener\">ISO 14644 cleanroom classification guide\u003C/a>.\u003C/p>\u003Ch2>Building Qualification Documentation From the Planning Stage\u003C/h2>\u003Cp>The costliest mistake QA teams often make is postponing IQ/OQ/PQ protocol planning until after construction is finished. Ideally, acceptance criteria for every parameter — particle count, ACH, differential pressure, microbial limits — should be agreed with the validation consultant during the DQ stage, so the sandwich panel contractor and HVAC installer both build toward the same target instead of guessing standards after the building is already up.\u003C/p>\u003Cp>Tidy documentation also speeds up BPOM audits and export-partner inspections: instrument calibration certificates, as-built drawings, test protocols with results, and requalification history are best kept in a single master validation plan binder that is easy to trace, rather than scattered across emails and separate project folders.\u003C/p>\u003Ch2>FAQ\u003C/h2>\u003Ch3>What is the main difference between IQ, OQ, and PQ in cleanroom qualification?\u003C/h3>\u003Cp>IQ verifies that physical components are installed per the design, OQ tests whether the system runs within set limits without personnel present, and PQ proves that performance stays consistent once the cleanroom is fully operating with personnel and production processes running.\u003C/p>\u003Ch3>How long does a cleanroom qualification certificate stay valid before requalification is needed?\u003C/h3>\u003Cp>Following EU GMP Annex 1 practice, Grade A and B areas are typically requalified at least every 6 months, while Grade C and D areas are requalified every 12 months — with additional requalification mandatory after significant changes to filters, HVAC, or the building envelope.\u003C/p>\u003Ch3>Does renovating cleanroom walls require a full requalification?\u003C/h3>\u003Cp>Not always a full restart from DQ, but OQ and PQ requalification of the affected area is mandatory, especially if the renovation changes panel joints, coving, or ducting routes that affect differential pressure and particle counts.\u003C/p>","\u003Cp>Kualifikasi cleanroom adalah proses pembuktian terdokumentasi bahwa ruang bersih benar-benar berfungsi sesuai desain dan mempertahankan tingkat kebersihan yang dipersyaratkan sepanjang siklus produksi. Bagi pabrik farmasi, alat kesehatan, dan makanan olahan steril di Indonesia, proses ini bukan formalitas administratif semata — kualifikasi yang gagal berarti fasilitas tidak boleh beroperasi sampai penyimpangan diperbaiki dan diuji ulang oleh pihak independen.\u003C/p>\u003Cp>Pertanyaan yang sering muncul dari pemilik proyek: kenapa dua cleanroom dengan spesifikasi HVAC yang mirip bisa mendapat hasil kualifikasi berbeda? Jawabannya sering ada pada detail yang jarang dibahas kompetitor — mulai dari kualitas sambungan panel dinding, kalibrasi instrumen uji, sampai urutan pengujian yang tidak mengikuti standar. Artikel ini merangkum tahapan DQ-IQ-OQ-PQ, parameter uji kritis, jadwal requalifikasi sesuai \u003Ca href=\"https://www.iso.org/standard/53394.html\" target=\"_blank\" rel=\"noopener\">ISO 14644-1:2015\u003C/a> dan EU GMP Annex 1, serta kaitannya dengan pemilihan material dinding cleanroom.\u003C/p>\u003Ch2>Apa Itu Kualifikasi Cleanroom dan Mengapa Wajib bagi Industri Farmasi?\u003C/h2>\u003Cp>Kualifikasi cleanroom (sering disebut juga validasi ruang bersih) adalah rangkaian pengujian yang membuktikan bahwa sistem HVAC, filter HEPA, dan selubung bangunan cleanroom benar-benar mencapai kelas kebersihan udara yang direncanakan — bukan sekadar diklaim dalam brosur desain. Di Indonesia, proses ini menjadi bagian wajib dari sertifikasi Cara Pembuatan Obat yang Baik (CPOB) yang diawasi BPOM untuk industri farmasi, serta menjadi syarat implisit sertifikasi GMP pangan dan alat kesehatan.\u003C/p>\u003Cp>Tanpa kualifikasi yang terdokumentasi, sebuah ruang bersih hanya berstatus \"ruangan ber-AC dengan filter\" — bukan cleanroom bersertifikat. Auditor BPOM maupun auditor internasional (FDA, EU GMP inspector untuk produk ekspor) akan meminta dokumen DQ, IQ, OQ, dan PQ sebagai bukti utama sebelum fasilitas dinyatakan layak produksi komersial.\u003C/p>\u003Ch2>Tahapan DQ, IQ, OQ, dan PQ dalam Kualifikasi Cleanroom\u003C/h2>\u003Cp>Kualifikasi cleanroom mengikuti urutan baku yang tidak boleh dilompati, karena setiap tahap menjadi prasyarat dokumentasi bagi tahap berikutnya:\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>Design Qualification (DQ)\u003C/strong> — memverifikasi bahwa gambar desain, pemilihan material dinding/langit-langit, tata letak ruang, dan spesifikasi HVAC sudah sesuai kebutuhan proses dan regulasi sejak sebelum konstruksi dimulai.\u003C/li>\u003Cli>\u003Cstrong>Installation Qualification (IQ)\u003C/strong> — memastikan seluruh komponen (unit AHU, filter HEPA, sensor tekanan/suhu, lampu UV, panel dinding, pintu interlock) terpasang sesuai spesifikasi desain, lengkap dengan sertifikat kalibrasi instrumen.\u003C/li>\u003Cli>\u003Cstrong>Operational Qualification (OQ)\u003C/strong> — menguji apakah sistem beroperasi sesuai batas yang ditetapkan dalam kondisi \"as built\" tanpa personel: kecepatan aliran udara, air change rate (ACH), beda tekanan antar ruang, uji kebocoran filter HEPA, dan hitung partikel kondisi diam (at rest).\u003C/li>\u003Cli>\u003Cstrong>Performance Qualification (PQ)\u003C/strong> — membuktikan cleanroom tetap memenuhi kelas kebersihan saat beroperasi penuh dengan personel dan peralatan produksi berjalan (in operation), termasuk pemantauan mikroba viable dan non-viable.\u003C/li>\u003C/ul>\u003Cp>Industri farmasi Indonesia umumnya membutuhkan 3-6 bulan untuk menuntaskan keempat tahap ini setelah konstruksi selesai, tergantung kompleksitas fasilitas dan kesiapan protokol validasi internal perusahaan.\u003C/p>\u003Cimg src=\"https://assets.sandwichpanels.id/blog/1785442474294-kualifikasi-cleanroom-hepa-filter-leak-test-inline-01.png\" alt=\"Teknisi menguji partikel udara dan tekanan diferensial di dalam cleanroom farmasi berdinding panel sandwich\" />\u003Ch2>Parameter Uji Kritis: Partikel, ACH, Tekanan, dan Kebocoran Filter\u003C/h2>\u003Cp>Beberapa parameter berikut menjadi fokus utama auditor saat menilai laporan OQ dan PQ:\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>Jumlah partikel udara\u003C/strong> — dihitung dengan particle counter sesuai ISO 14644-1, dibandingkan terhadap batas kelas ISO (misalnya ISO 5 setara Grade A/B EU GMP).\u003C/li>\u003Cli>\u003Cstrong>Air Change Rate (ACH)\u003C/strong> — jumlah pergantian udara per jam, memastikan partikel dan kontaminan terdilusi secepat yang direncanakan pada tahap DQ.\u003C/li>\u003Cli>\u003Cstrong>Beda tekanan diferensial\u003C/strong> — menjaga arah aliran udara dari area lebih bersih ke area kurang bersih agar kontaminan tidak masuk balik.\u003C/li>\u003Cli>\u003Cstrong>Uji kebocoran filter HEPA\u003C/strong> — memakai aerosol fotometer untuk memastikan tidak ada kebocoran pada media filter maupun sambungan frame filter, mengacu pada metodologi ISO 14644-3.\u003C/li>\u003Cli>\u003Cstrong>Uji visualisasi asap (smoke study)\u003C/strong> — khusus zona unidirectional/laminar Grade A, membuktikan pola aliran udara benar-benar searah tanpa turbulensi di titik kritis.\u003C/li>\u003Cli>\u003Cstrong>Pemantauan mikroba viable\u003C/strong> — settle plate, contact plate, dan active air sampling, dengan batas paling ketat di Grade A (tidak boleh ada pertumbuhan koloni pada contact plate) dan Grade B (maksimal 5 CFU per plate).\u003C/li>\u003C/ul>\u003Ch2>Frekuensi Requalifikasi Sesuai ISO 14644-2 dan EU GMP Annex 1\u003C/h2>\u003Cp>Revisi ISO 14644-2:2015 menghapus tabel jadwal baku dari edisi sebelumnya dan mewajibkan setiap fasilitas menyusun jadwal requalifikasi berbasis risiko sendiri. Namun EU GMP Annex 1 (revisi 2022) tetap memberi acuan praktis yang banyak diadopsi industri: requalifikasi maksimal setiap 6 bulan untuk Grade A dan B, serta setiap 12 bulan untuk Grade C dan D.\u003C/p>\u003Cp>Requalifikasi tambahan wajib dilakukan begitu ada perubahan signifikan — penggantian filter HEPA, modifikasi ducting HVAC, renovasi dinding/langit-langit, atau perubahan tata letak peralatan produksi. Mengandalkan sertifikat lama setelah perubahan semacam ini adalah salah satu penyebab paling umum kegagalan audit BPOM maupun inspeksi ekspor.\u003C/p>\u003Ch2>Peran Material Dinding Sandwich Panel dalam Lolos Kualifikasi\u003C/h2>\u003Cp>Banyak kegagalan IQ dan OQ sebenarnya berakar dari pemilihan dan pemasangan material selubung ruangan, bukan dari sistem HVAC itu sendiri. Sambungan panel yang tidak rapat, sealant yang menyusut, atau sudut pertemuan dinding-lantai tanpa coving melengkung akan membocorkan udara dan menjadi titik akumulasi partikel — persis yang diuraikan pada artikel kami tentang \u003Ca href=\"https://sandwichpanels.id/blog/kesalahan-material-dinding-cleanroom-gagal-sertifikasi-2026\" target=\"_blank\" rel=\"noopener\">kesalahan material dinding cleanroom penyebab gagal sertifikasi\u003C/a>.\u003C/p>\u003Cp>Panel sandwich core PU/PIR dengan permukaan pre-painted galvanized steel dan sistem sambungan tongue-and-groove yang presisi membantu menjaga integritas tekanan diferensial saat OQ, karena kebocoran udara antar ruang jauh lebih kecil dibanding dinding konvensional yang disekat gipsum atau bata plester. Detail klasifikasi kelas kebersihan dan hubungannya dengan pemilihan spesifikasi bangunan bisa dibaca lebih lengkap pada \u003Ca href=\"https://sandwichpanels.id/blog/klasifikasi-cleanroom-iso-14644-panduan-kelas-standar-2026\" target=\"_blank\" rel=\"noopener\">panduan klasifikasi cleanroom ISO 14644\u003C/a> kami.\u003C/p>\u003Ch2>Menyiapkan Dokumen Kualifikasi Sejak Tahap Perencanaan\u003C/h2>\u003Cp>Kesalahan paling mahal yang sering ditemui tim QA adalah menunda perencanaan protokol IQ/OQ/PQ sampai konstruksi selesai. Idealnya, kriteria keberterimaan (acceptance criteria) untuk setiap parameter — jumlah partikel, ACH, beda tekanan, batas mikroba — sudah disepakati bersama konsultan validasi sejak tahap DQ, sehingga kontraktor sandwich panel dan instalator HVAC bekerja mengacu pada target yang sama, bukan menebak-nebak standar setelah bangunan berdiri.\u003C/p>\u003Cp>Dokumentasi yang rapi juga mempercepat audit BPOM maupun inspeksi mitra ekspor: sertifikat kalibrasi instrumen, gambar as-built, protokol uji beserta hasilnya, dan riwayat requalifikasi sebaiknya disimpan dalam satu berkas master validation plan yang mudah ditelusuri, bukan tersebar di email atau folder proyek yang berbeda-beda.\u003C/p>\u003Ch2>FAQ\u003C/h2>\u003Ch3>Apa perbedaan utama antara IQ, OQ, dan PQ pada kualifikasi cleanroom?\u003C/h3>\u003Cp>IQ memverifikasi bahwa komponen fisik terpasang sesuai desain, OQ menguji apakah sistem beroperasi dalam batas yang ditetapkan tanpa personel, dan PQ membuktikan kinerja tersebut tetap konsisten saat cleanroom beroperasi penuh dengan personel dan proses produksi berjalan.\u003C/p>\u003Ch3>Berapa lama masa berlaku sertifikat kualifikasi cleanroom sebelum harus requalifikasi?\u003C/h3>\u003Cp>Mengacu pada praktik EU GMP Annex 1, Grade A dan B umumnya direqualifikasi setiap maksimal 6 bulan, sedangkan Grade C dan D setiap 12 bulan — dengan requalifikasi tambahan wajib setelah perubahan signifikan pada filter, HVAC, atau selubung bangunan.\u003C/p>\u003Ch3>Apakah renovasi dinding cleanroom mengharuskan kualifikasi ulang penuh?\u003C/h3>\u003Cp>Tidak selalu penuh dari DQ, tetapi requalifikasi OQ dan PQ pada area yang terdampak wajib dilakukan, terutama bila renovasi mengubah sambungan panel, coving, atau jalur ducting yang memengaruhi tekanan diferensial dan jumlah partikel.\u003C/p>","\u003Cp>洁净室确认是通过文件证明洁净空间确实按设计运行、并在整个生产周期内维持所需洁净度等级的过程。对印尼的制药厂、医疗器械企业和无菌食品加工厂而言，这绝非纸面手续——一旦确认失败，工厂在偏差被纠正并由独立机构复测之前将无法合法运营。\u003C/p>\u003Cp>项目负责人常问：为何两间HVAC规格相近的洁净室，确认结果却大不相同？答案往往藏在细节里——墙板拼缝质量、仪器校准、或漏做某检验步骤。本文梳理DQ-IQ-OQ-PQ阶段、关键参数、依据\u003Ca href=\"https://www.iso.org/standard/53394.html\" target=\"_blank\" rel=\"noopener\">ISO 14644-1:2015\u003C/a>与GMP附录1的复检周期，以及墙材与认证的关系。\u003C/p>\u003Ch2>什么是洁净室确认？为何制药行业必须做？\u003C/h2>\u003Cp>洁净室确认（也称洁净空间验证）是一系列测试，证明HVAC系统、HEPA过滤器与建筑围护结构真正达到设计规划的洁净度等级，而不只是设计手册上的宣称。在印尼，这是BPOM监管的CPOB（药品生产质量管理规范）认证的强制环节，也是食品GMP与医疗器械认证的隐性要求。\u003C/p>\u003Cp>没有文件化确认，洁净空间只是\"带过滤器的空调房\"，算不上认证洁净室。BPOM审计员及国际检查员（面向出口产品的FDA、EU GMP检查员）都会要求提供DQ、IQ、OQ、PQ文件，作为工厂获准商业化生产前的主要证据。\u003C/p>\u003Ch2>洁净室确认的DQ、IQ、OQ、PQ四阶段\u003C/h2>\u003Cp>洁净室确认遵循固定顺序，不可跳步，因为每个阶段都是下一阶段的文件前提：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>设计确认（DQ）\u003C/strong>——在施工开始前，核实布局图纸、墙体/天花材料选择、房间相邻关系与HVAC规格是否满足工艺与法规要求。\u003C/li>\u003Cli>\u003Cstrong>安装确认（IQ）\u003C/strong>——确认AHU机组、HEPA过滤器、压差/温度传感器、紫外灯、墙板、互锁门等所有部件均按设计规格安装，并附仪器校准证书。\u003C/li>\u003Cli>\u003Cstrong>运行确认（OQ）\u003C/strong>——在\"竣工态\"无人条件下测试系统是否在设定限值内运行：风速、换气次数（ACH）、房间间压差、HEPA过滤器泄漏测试及静态粒子计数。\u003C/li>\u003Cli>\u003Cstrong>性能确认（PQ）\u003C/strong>——证明洁净室在人员与生产设备全面运行的\"动态\"状态下，仍能维持所需洁净度等级，包括活性与非活性微生物监测。\u003C/li>\u003C/ul>\u003Cp>印尼制药企业完成施工后，通常需要3至6个月完成上述四个阶段，具体取决于设施复杂度与企业内部验证流程的成熟度。\u003C/p>\u003Cimg src=\"https://assets.sandwichpanels.id/blog/1785442474294-kualifikasi-cleanroom-hepa-filter-leak-test-inline-01.png\" alt=\"技术人员在夹芯板洁净室内检测空气粒子浓度与压差\" />\u003Ch2>关键测试参数：粒子、换气次数、压差与过滤器泄漏\u003C/h2>\u003Cp>以下参数是审计员评审OQ与PQ报告时的核心关注点：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>悬浮粒子浓度\u003C/strong>——依据ISO 14644-1用粒子计数器测量，并与ISO等级限值（ISO 5大致对应EU GMP A/B级）比对。\u003C/li>\u003Cli>\u003Cstrong>换气次数（ACH）\u003C/strong>——每小时换气次数，确保污染物按DQ阶段规划的速度被稀释。\u003C/li>\u003Cli>\u003Cstrong>房间压差\u003C/strong>——维持气流从洁净区流向次洁净区，防止污染物逆向侵入。\u003C/li>\u003Cli>\u003Cstrong>HEPA过滤器泄漏测试\u003C/strong>——用气溶胶光度计确认滤材及边框密封无泄漏，遵循ISO 14644-3方法。\u003C/li>\u003Cli>\u003Cstrong>烟雾可视化测试\u003C/strong>——针对单向流/层流A级区域，证明气流模式确实单向、关键点无湍流。\u003C/li>\u003Cli>\u003Cstrong>活菌监测\u003C/strong>——沉降皿、接触皿与主动空气采样，A级最严（接触皿不得有菌落生长），B级每皿限5个菌落形成单位。\u003C/li>\u003C/ul>\u003Ch2>依据ISO 14644-2与EU GMP附录1的复检周期\u003C/h2>\u003Cp>ISO 14644-2:2015修订版取消了旧版固定的复检周期表，要求各设施自行制定基于风险的复检计划。不过EU GMP附录1（2022修订版）仍提供业界广泛采纳的实用基准：A级与B级区域最长每6个月复检一次，C级与D级区域最长每12个月一次。\u003C/p>\u003Cp>一旦发生重大变更——更换HEPA过滤器、HVAC风管改造、墙体或天花翻新、生产设备布局调整——都必须额外复检。变更后仍沿用旧证书，是BPOM审计与出口检查最常见的失败原因之一。\u003C/p>\u003Ch2>夹芯板墙体材料如何影响确认结果\u003C/h2>\u003Cp>许多IQ与OQ失败其实源于围护结构材料及其安装质量，而非HVAC系统本身。拼缝松动、密封胶收缩、或墙地交界处缺少弧形圆角（coving）都会漏风，并形成粒子聚积点——这正是我们文章《\u003Ca href=\"https://sandwichpanels.id/zh/blog/kesalahan-material-dinding-cleanroom-gagal-sertifikasi-2026\" target=\"_blank\" rel=\"noopener\">导致认证失败的洁净室墙面材料错误\u003C/a>》详述的问题。\u003C/p>\u003Cp>PU/PIR芯材夹芯板配合预涂镀锌钢板面材与精密企口拼接，能在OQ测试中更好地维持压差完整性，因为其房间间漏风远低于传统石膏隔断或抹灰砖墙。关于洁净度等级分类及其与建筑规格选择的关系，可参阅我们的《\u003Ca href=\"https://sandwichpanels.id/zh/blog/klasifikasi-cleanroom-iso-14644-panduan-kelas-standar-2026\" target=\"_blank\" rel=\"noopener\">ISO 14644洁净室分级指南\u003C/a>》。\u003C/p>\u003Ch2>从规划阶段就准备好确认文件\u003C/h2>\u003Cp>QA团队最常见、代价也最高的失误，是把IQ/OQ/PQ方案规划拖到施工完成之后。理想做法是在DQ阶段就与验证顾问商定各参数的可接受标准——粒子数、ACH、压差、微生物限值——让夹芯板承包商与HVAC安装商朝同一目标施工，而非等建筑建成后再猜测标准。\u003C/p>\u003Cp>整齐的文件同样能加快BPOM审计与出口伙伴检查：仪器校准证书、竣工图纸、测试方案及结果、复检记录，最好统一归档于一份易于追溯的主验证计划，而非散落在邮件与不同项目文件夹中。\u003C/p>\u003Ch2>FAQ\u003C/h2>\u003Ch3>洁净室确认中IQ、OQ、PQ的主要区别是什么？\u003C/h3>\u003Cp>IQ核实实体部件是否按设计安装，OQ测试系统在无人条件下是否在设定限值内运行，PQ则证明洁净室在人员与生产流程全面运行时性能依然保持一致。\u003C/p>\u003Ch3>洁净室确认证书有效期多久，何时需要复检？\u003C/h3>\u003Cp>依据EU GMP附录1惯例，A级与B级区域通常最长每6个月复检一次，C级与D级区域每12个月一次；过滤器、HVAC或建筑围护结构发生重大变更后，也必须额外复检。\u003C/p>\u003Ch3>翻新洁净室墙体是否需要全面重新确认？\u003C/h3>\u003Cp>不一定要从DQ重新开始，但受影响区域的OQ与PQ复检是强制性的，尤其当翻新改变了墙板拼缝、圆角或风管路径，进而影响压差与粒子数时。\u003C/p>","https://assets.sandwichpanels.id/blog/1785442472045-kualifikasi-cleanroom-iq-oq-pq-particle-count-cover-01.png","2026-07-30T20:20:18.512798Z",{"en":55,"id":56,"zh":57},"Cleanroom qualification is the documented process of proving that a clean space genuinely operates as designed and sustains the required cleanliness class throughout the production cycle. For pharmace...","Kualifikasi cleanroom adalah proses pembuktian terdokumentasi bahwa ruang bersih benar-benar berfungsi sesuai desain dan mempertahankan tingkat kebersihan yang dipersyaratkan sepanjang siklus produksi...","洁净室确认是通过文件证明洁净空间确实按设计运行、并在整个生产周期内维持所需洁净度等级的过程。对印尼的制药厂、医疗器械企业和无菌食品加��...","610a6173-f7c8-44e1-8808-cfb28b8344d9",true,"2026-07-31T02:16:11.82101Z",{"title":62,"description":66},{"en":63,"id":64,"zh":65},"Cleanroom Qualification IQ OQ PQ Guide for Pharma 2026","Kualifikasi Cleanroom Farmasi: IQ OQ PQ Sesuai CPOB 2026","洁净室确认IQ/OQ/PQ指南：CPOB与ISO14644",{"en":67,"id":68,"zh":69},"Guide to cleanroom qualification: DQ-IQ-OQ-PQ stages, particle & ACH parameters, ISO 14644-2 and EU GMP Annex 1 requalification schedule, and the role of wall material.","Panduan kualifikasi cleanroom farmasi: tahapan DQ-IQ-OQ-PQ, parameter uji partikel & ACH, jadwal requalifikasi ISO 14644-2, EU GMP Annex 1, dan peran material dinding.","洁净室确认完整指南：DQ-IQ-OQ-PQ阶段、粒子与换气次数参数、ISO14644-2与EU 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& Applications","Industri & Aplikasi","行业与应用","industri","https://assets.sandwichpanels.id/blog/1786652012493-sandwich-panel-data-center-konstruksi-modular-2026.png","2026-08-12T20:28:58.745519Z",{"en":292,"id":293,"zh":294},"Installed data center capacity in Indonesia reached roughly 520 MW by June 2026. IDPRO chairman Hendra Suryakusuma expects the national figure to approach 600 MW by year end, driven by projects now en...","Kapasitas fasilitas data center di Indonesia menyentuh sekitar 520 MW sampai Juni 2026. Ketua Umum IDPRO Hendra Suryakusuma memperkirakan angka itu bisa mendekati 600 MW di penghujung tahun, ditopang ...","截至2026年6月，印尼已建成的数据中心容量约为520兆瓦。印尼数据中心产业协会（IDPRO）主席Hendra Suryakusuma预计，随着多个项目进入施工、通电与调试阶�...","80e08120-6448-4e7e-a60a-585a70c450b2","2026-08-13T02:18:40.179129Z","sandwich-panel-data-center-konstruksi-modular-2026",[299,300,301,302,303,304,305],"sandwich panel data center","konstruksi data center indonesia","NFPA 75","TIA-942","ASHRAE TC 9.9","panel rockwool tahan api","modular data center",{"en":307,"id":308,"zh":309},"Sandwich Panels for Data Centers: Fire-Rated Build 2026","Sandwich Panel Data Center: Konstruksi Modular Tahan Api 2026","数据中心夹芯板：模块化防火建造指南2026","2026-08-13T20:13:36.359217Z",{"author_name":41,"category":312,"cover_image":314,"created_at":315,"excerpt":316,"id":320,"published_at":321,"slug":322,"tags":323,"title":331,"updated_at":321},{"name":313,"slug":288},{"en":285,"id":286,"zh":287},"https://assets.sandwichpanels.id/blog/1786479336522-sandwich-panel-cold-storage-container-mobile-cold-room-cover-01.png","2026-08-11T20:21:41.478687Z",{"en":317,"id":318,"zh":319},"Fishermen along Java's northern coast routinely hold their catch for hours before a collector's truck arrives. Horticulture growers face the same squeeze. Permanent cold storage sits too far from the ...","Nelayan di pantai utara Jawa sering menahan hasil tangkapan berjam-jam sebelum truk pengepul datang. Petani hortikultura menghadapi persoalan serupa. Cold storage permanen terlalu jauh dari titik pane...","爪哇北岸的渔民常常要等上几个小时，收购车才会抵达码头。园艺种植户面临同样的困境：固定式冷库离产地太远、容量过大、投资回报算不过来。集��...","8c116a8f-bd98-415c-96e2-1b00d7a7240b","2026-08-12T03:05:12.276049Z","sandwich-panel-cold-storage-container-mobile-cold-room-2026",[324,325,326,327,328,329,330],"cold storage container","mobile cold room","cold room portable","sandwich panel PIR","ketebalan panel cold storage","rantai dingin perikanan","reefer container",{"en":332,"id":333,"zh":334},"Container Cold Storage & Mobile Cold Rooms Guide 2026","Cold Storage Container & Mobile Cold Room Panel 2026","集装箱冷库与移动冷藏室：夹芯板选型指南2026",{"author_name":41,"category":336,"cover_image":338,"created_at":339,"excerpt":340,"id":344,"published_at":345,"slug":346,"tags":347,"title":355,"updated_at":345},{"name":337,"slug":288},{"en":285,"id":286,"zh":287},"https://assets.sandwichpanels.id/blog/1786393070543-sandwich-panel-pabrik-baterai-ev-dry-room-cover-01.png","2026-08-10T20:21:34.205599Z",{"en":341,"id":342,"zh":343},"Indonesia's electric vehicle (EV) battery industry has entered a new phase. The battery plant of PT CATL Amperex Technology Indonesia Battery (CATIB), a joint venture between Contemporary Amperex Tech...","Industri baterai kendaraan listrik (EV) Indonesia memasuki babak baru. Pabrik baterai PT CATL Amperex Technology Indonesia Battery (CATIB), hasil kerja sama Contemporary Amperex Technology Co. Limited...","印度尼西亚电动汽车（EV）电池产业迈入新阶段。由宁德时代（CATL）子公司CBL与印尼电池公司（IBC）合资的PT CATL Amperex Technology Indonesia Battery（CATIB）电�...","460950c8-6e0f-44af-8b1f-707d02338c6d","2026-08-11T02:16:05.725517Z","sandwich-panel-pabrik-baterai-ev-dry-room-2026",[348,349,350,351,352,353,354],"sandwich panel pabrik baterai ev","dry room baterai","PIR sandwich panel","fire rating EI60 EI120","cleanroom industri","CATL Karawang","konstruksi pabrik baterai",{"en":356,"id":357,"zh":358},"Sandwich Panels for EV Battery Plants & Dry Rooms 2026","Sandwich Panel Pabrik Baterai EV & Dry Room 2026","EV电池工厂与干燥室夹芯板建造指南2026",{"author_name":41,"category":360,"cover_image":366,"created_at":367,"excerpt":368,"id":372,"published_at":373,"slug":374,"tags":375,"title":383,"updated_at":373},{"name":361,"slug":365},{"en":362,"id":363,"zh":364},"Product Comparisons","Perbandingan Produk","产品比较","perbandingan","https://assets.sandwichpanels.id/blog/1786306267791-sandwich-panel-vs-acp-aluminium-composite-panel-cover-01.png","2026-08-09T20:15:18.683434Z",{"en":369,"id":370,"zh":371},"Many buyers assume ACP (Aluminium Composite Panel) and sandwich panel are the same product because both get installed as an exterior wall layer. In reality they are fundamentally different: ACP is a d...","Banyak calon pembeli mengira ACP (Aluminium Composite Panel) dan sandwich panel adalah produk yang sama karena sama-sama dipasang sebagai lapisan dinding luar bangunan. Padahal keduanya berbeda secara...","很多客户以为ACP铝塑板和夹芯板是同一种材料，因为两者都安装在建筑外墙表面。实际上二者本质完全不同：ACP是一种纯装饰性幕墙材料，不具备结构��...","0736e4bc-30e8-4003-a07c-c6be28c7a400","2026-08-10T02:16:32.442421Z","sandwich-panel-vs-acp-perbedaan-dan-cara-memilih-2026",[376,377,378,379,380,381,382],"sandwich panel vs acp","aluminium composite panel","perbandingan material fasad","EN 14509","SNI 1741","fire rating panel","material dinding pabrik",{"en":384,"id":385,"zh":386},"Sandwich Panel vs ACP: Key Differences & How to Choose 2026","Sandwich Panel vs ACP: Perbedaan dan Cara Memilih 2026","夹芯板与ACP铝塑板：区别与选购指南2026",{"author_name":41,"category":388,"cover_image":390,"created_at":391,"excerpt":392,"id":396,"published_at":397,"slug":398,"tags":399,"title":403,"updated_at":397},{"name":389,"slug":47},{"en":44,"id":45,"zh":46},"https://assets.sandwichpanels.id/blog/1786219846540-bahan-dinding-cleanroom-panduan-pemilihan-sandwich-panel-2026-cover-01.png","2026-08-08T20:16:05.976199Z",{"en":393,"id":394,"zh":395},"Choosing the wrong cleanroom wall material is never just a cosmetic mistake. A panel with the wrong specification can trigger excess particle shedding, become hard to clean, or fail a GMP/CPOB audit o...","Kesalahan memilih bahan dinding cleanroom bukan sekadar soal estetika. Panel yang salah spesifikasi bisa memicu partikulasi berlebih, sulit dibersihkan, atau bahkan gagal audit CPOB/GMP saat inspeksi ...","洁净室墙面材料选错绝不只是外观问题。规格不当的夹芯板会导致颗粒物脱落超标、难以清洁,甚至在BPOM的CPOB审计中直接不合格。本文从技术角度讲解��...","611ca269-0aec-4a7a-843f-3e0d93d6a6c4","2026-08-09T02:16:22.637543Z","bahan-dinding-cleanroom-panduan-pemilihan-sandwich-panel-2026",[400,72,78,76,75,401,402],"bahan dinding cleanroom","core PU PIR rockwool","hairline joint cleanroom",{"en":404,"id":405,"zh":406},"Cleanroom Wall Materials: Sandwich Panel Selection Guide 2026","Bahan Dinding Cleanroom: Panduan Pemilihan Sandwich Panel 2026","洁净室墙面材料：夹芯板选型指南2026",175]