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Protokol Kontaminasi 2026-08-05 • 6 Menit Baca

Pass Box Cleanroom — Perbedaan Static & Dynamic Pass Box

Panduan lengkap memahami perbedaan Static dan Dynamic Pass Box. Pelajari fungsi utama, keunggulan, serta standar penggunaannya di cleanroom ISO 14644 dan cGMP.

Pass Box — Pass Box Statis & Dinamis untuk Transfer Material Cleanroom

Pass box adalah perangkat transfer penting yang digunakan untuk memindahkan material antar ruangan cleanroom atau antara lingkungan terkontrol dan non-terkontrol. Pass box membantu mempertahankan tingkat kebersihan, meminimalkan kontaminasi partikel, serta mengurangi pergerakan personel yang tidak perlu. Dengan pemilihan dan instalasi yang tepat, pass box dapat meningkatkan efisiensi alur kerja secara signifikan serta mengurangi beban sistem HVAC di fasilitas farmasi, semikonduktor, bioteknologi, dan perakitan optik presisi.

Farclean memproduksi Static Pass Box dan Dynamic Pass Box dengan struktur baja tahan karat (stainless steel SUS304/SUS316), penyegelan kedap udara, opsi filtrasi HEPA/ULPA, serta sistem interlock canggih sesuai standar ISO 14644 dan regulasi GMP.

Apa Itu Pass Box Cleanroom?

Pass box adalah ruang transfer tertutup khusus yang dipasang pada dinding partisi cleanroom untuk memindahkan material antar ruangan dengan klasifikasi kebersihan berbeda. Tujuan utamanya adalah mencegah kontaminasi silang, menjaga kaskade tekanan udara, dan mengurangi kehilangan udara terkondisi antar ruangan.

Aplikasi umum pass box meliputi:

  • Transfer bahan baku, perkakas, dan produk setengah jadi
  • Pemindahan sampel laboratorium, reagen kimia, atau peralatan instrumen kecil
  • Pengiriman kemasan steril atau wadah produksi
  • Mencegah kontaminasi silang antar zona cleanroom yang bersebelahan

1. Static Pass Box (Pass Box Statis)

Static Pass Box dipasang di antara dua ruangan yang memiliki tingkat kebersihan yang sama atau setara. Tipe ini tidak memiliki kipas blower internal atau sistem filter HEPA, melainkan sepenuhnya mengandalkan pintu ber-interlock mekanis atau elektronik untuk menjaga isolasi udara. Pass box statis banyak diaplikasikan di laboratorium, ruang pengemasan, area pengolahan makanan, dan lingkungan bersih berisiko rendah.

Fitur Utama:

  • Ruang dalam stainless steel SUS304/SUS316 tahan karat
  • Sistem interlock mekanis atau elektromagnetik
  • Jendela kaca temper (view panel) untuk observasi
  • Sudut lengkung (coved interior) mudah dibersihkan
  • Opsi lampu UV germisidal untuk sterilisasi permukaan

Keunggulan:

  • Investasi awal lebih ekonomis
  • Struktur sederhana, minim perawatan
  • Tanpa konsumsi daya listrik tambahan untuk blower

2. Dynamic Pass Box (Pass Box Dinamis)

Dynamic Pass Box dilengkapi sistem filtrasi HEPA/ULPA mandiri dan beroperasi dengan aliran udara bertekanan positif. Pass box dinamis wajib digunakan saat mentransfer material dari area dengan kelas kebersihan lebih rendah ke area cleanroom yang lebih tinggi (misalnya Grade D ke Grade B). Unit ini berfungsi layaknya ruang pembersih mini berkecepatan tinggi, menyapu debu dan partikel dari permukaan benda sebelum pintu sisi ruang steril dapat dibuka.

Fitur Utama:

  • Filter HEPA H13/H14 efisiensi tinggi (99,995% pada 0,3 µm) atau ULPA
  • Motor kipas EC menyediakan aliran udara laminar stabil
  • Tampilan digital indikator tekanan (differential pressure gauge)
  • Interlock elektromagnetik dengan timer purge otomatis
  • Opsi kontrol layar sentuh PLC & port sampling

Keunggulan:

  • Menjamin kebersihan permukaan material saat ditransfer
  • Kepatuhan penuh standar cGMP PIC/S dan FDA/GMP
  • Mempertahankan tekanan positif dan mencegah kontaminasi aliran balik

Perbandingan Komprehensif: Static vs. Dynamic Pass Box

Parameter Kunci Static Pass Box Dynamic Pass Box
Aliran UdaraTanpa kipas atau filterAliran laminar terfilter HEPA/ULPA
Pengendalian KontaminasiKontrol kontaminasi dasarPembersihan partikel tingkat tinggi
Aplikasi TerbaikLingkungan ISO 7–8 yang setaraISO 5–7, zona GMP Grade A/B/C
Persyaratan InstalasiKonstruksi minimalMembutuhkan pasokan daya listrik & desain aliran
Investasi BiayaLebih ekonomisInvestasi lebih tinggi sesuai spesifikasi

Keunggulan Pass Box Produksi Farclean

  • Struktur baja tahan karat bermutu tinggi dengan masa pakai panjang
  • Gasket segel kedap udara dan engsel presisi standar cleanroom internasional
  • Pemasangan mudah pada panel modular maupun dinding partisi konvensional
  • Tersedia berbagai dimensi standar serta ukuran kustom sesuai tata letak proyek
  • Kustomisasi penuh: sistem interlock, timer purging, filtrasi, dan otomasi PLC

Aplikasi Lintas Industri

  • Fasilitas manufaktur farmasi & bahan farmasi aktif (API)
  • Laboratorium keselamatan hayati (biosafety) dan mikrobiologi
  • Fabrikasi wafer semikonduktor dan pabrik mikroelektronika
  • Pabrik instrumen bedah dan perangkat medis steril
  • Cleanroom lensa optik, layar sentuh, dan perakitan presisi
  • Produksi makanan steril, kosmetik, dan nutraseutikal

Kesimpulan

Pass box adalah perangkat penting untuk menjaga integritas ruang bersih dan melindungi kualitas produk dari kontaminasi silang. Farclean menyediakan rangkaian lengkap pass box statis dan dinamis yang dirancang untuk berbagai kebutuhan industri dan kelas kebersihan. Dengan kustomisasi fleksibel dan standar pengujian ketat, kami membantu pelanggan membangun fasilitas produksi yang aman, efisien, dan patuh regulasi.

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Contamination Protocol 08-05-2026 • 6 Minute Read
Cleanroom Pass Box — Difference between Static & Dynamic Pass Box

Complete guide to understanding the differences between Static and Dynamic Pass Boxes. Learn the main functions, advantages and standards for use in ISO 14644 and cGMP cleanrooms.

Pass Box — Pass Box Statis & Dinamis untuk Transfer Material Cleanroom

Pass box is an essential transfer device used to move materials between cleanrooms or between controlled and non-controlled environments. Pass boxes help maintain cleanliness levels, minimize particle contamination, and avoid unnecessary personnel movement. With proper selection and installation, pass boxes can significantly increase workflow efficiency and reduce the workload on a facility's HVAC system pharmaceuticals, semiconductors, biotechnology, and precision optical assembly.

Farclean manufactures Static Pass Box And Dynamic Pass Box with a stainless steel structure (stainless steel SUS304/SUS316), airtight sealing, HEPA/ULPA filtration options, as well as an advanced interlock system that complies with ISO 14644 standards and GMP regulations.

What is a Cleanroom Pass Box?

A pass box is a special closed transfer space installed on a cleanroom partition wall to move goods between rooms with different cleanliness classifications. The primary goals are to prevent cross-contamination, maintain air pressure cascades, and limit the loss of sterile air between rooms.

Common pass box applications include:

  • Movement of raw materials, tools and semi-finished products
  • Transfer of laboratory samples, chemical reagents, or small instrument equipment
  • Delivery of sterile packaging or production containers
  • Prevents cross-contamination between adjacent cleanroom zones

1. Static Pass Box (Static Pass Box)

Static Pass Box installed between two rooms that have the same or equivalent cleanliness class level. This type does not have an internal blower fan or HEPA filter system, but instead relies entirely on doors with mechanical or electronic interlocks to maintain air isolation. Static pass boxes are widely applied in laboratories, packaging rooms, food processing areas and low-risk clean environments.

Key Features:

  • Rust-proof SUS304/SUS316 stainless steel inner chamber
  • Mechanical or electromagnetic interlock system
  • Tempered glass view panel window for observation
  • Curved corners (coved interior) are easy to clean
  • Germicidal UV lamp option for surface sterilization

Superiority:

  • Initial investment is more economical
  • Simple structure, minimal maintenance
  • No additional electrical power consumption for the blower

2. Dynamic Pass Box (Dynamic Pass Box)

Dynamic Pass Box equipped with a self-contained HEPA/ULPA filtration system and operates with positive pressure air flow. A dynamic pass box must be used when transferring material from an area with a lower cleanroom class to a higher cleanroom area (e.g. Grade D to Grade B). This tool functions like a mini high-speed cleaning room, sweeping dust and particles from the surface of objects before the side door of the sterile room can be opened.

Key Features:

  • High efficiency H13/H14 HEPA filter (99.995% at 0.3μm) or ULPA
  • EC fan motor provides stable laminar air flow
  • Digital display of pressure indicator (differential pressure gauge)
  • Electromagnetic interlock with automatic purge timer
  • PLC touch screen control option & sampling port

Superiority:

  • Guarantees the cleanliness of the material surface when transferred
  • Full cGMP PIC/S and FDA/GMP standards compliance
  • Maintains positive pressure and prevents back contamination

Comprehensive Comparison: Static vs. Static Dynamic Pass Box

Key Parameters Static Pass Box Dynamic Pass Box
AirflowNo fan or filterHEPA/ULPA filtered laminar flow
Contamination ControlBasic contamination controlHigh degree of particle cleaning
Best ApplicationISO 7–8 environment equivalentISO 5–7, GMP Grade A/B/C zones
Installation RequirementsMinimal constructionRequires electrical power supply & flow design
Cost InvestmentMore economicalHigher investment according to specifications

Advantages of Farclean Production Pass Boxes

  • High-grade stainless steel structure with long service life
  • Airtight seal gaskets and international cleanroom standard precision hinges
  • Easy installation on modular panels or conventional partition walls
  • Various standard dimensions as well as custom sizes are available to suit the project layout
  • Full customization: interlock system, cleaning timer, filtration and PLC automation

Cross-Industry Applications

  • Pharmaceutical manufacturing facilities & active drug raw materials (API)
  • Biosafety and microbiology laboratory
  • Semiconductor wafer fabrication and microelectronics manufacturing
  • Manufacture of sterile surgical instruments and medical devices
  • Cleanroom of optical lenses, touch screens and precision assembly
  • Production of sterile foods, cosmetics and nutraceuticals

Conclusion

Pass boxes are an irreplaceable instrument for maintaining cleanroom integrity and protecting product quality from cross-contamination. Farclean provides a complete range of static and dynamic pass boxes designed for a variety of industrial needs and cleaning classes. With flexible customization and stringent testing standards, we help customers build safe, efficient and compliant production facilities.

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