引用

医療用乾燥剤

The Medical Industry Desiccants are moisture management products for mission critical applications. The Medical Industry Desiccants are used to protect from moisture sensitive medical equipment, pharmaceuticals, diagnostics, and devices while in transport, storage and/or use. They are designed to capture and hold on to ambient moisture vapor to prevent condensation, chemical degradation, loss of pharmaceutical potency, growth of microbes, and corrosion of metal components. The primary forms are: high-purity silica gel (which consistently comply with USP / EP), molecular sieves, where clay (desiccants are packaged in Tyvek® pouches or canisters intended for use in cleanroom applications). Having an understanding of regulatory practices to ensure compliance is critically important to maintain the integrity and sterility of the products .Some mission critical applications include: protecting moisture-sensitive medications and vaccines, in their vials or packaging; protecting humidity sensitive surgical and electronic medical devices during transport and storage; maintaining diagnostic reagents and test kits’ stability, accuracy or shelf-life; providing sterility for implantable devices. It is also highly regulated which involves different investigations, defined material specifications, functional safety and purity investigations, cleanliness and performance. Selecting the suitable type, capacity and style of desiccant is important to ensure integrity and shelf-life of medical products through the supply chain and ensure the functionality of life-saving medical products.

業界の課題

egulatory & Safety Compliance

  • Meeting strict global regulations (FDA, EMA) for biocompatibility, safety (e.g., USP Class VI), and purity.
  • Ensuring minimal leachables/extractables and comprehensive traceability.
  • Proving safety for direct contact with drugs/devices, critical for all types (silica, montmorillonite, fiber, Ca/Mg chlorides).

Material Performance & Integrity

  • Maintaining ultra-high material purity across all desiccant types to prevent product contamination.
  • Ensuring compatibility with protected products (e.g., avoiding corrosion from chlorides like CaCl₂/MgCl₂, dusting from clays like attapulgite/montmorillonite).
  • Preventing physical degradation (e.g., breakage, dusting) that could harm devices/drugs.

Packaging & Process Requirements

  • Developing robust packaging (e.g., Tyvek® for silica gel, fiber) that withstands sterilization (gamma, ETO, e-beam) without failing.
  • Minimizing linting/dust generation during handling and use (particularly relevant for clay desiccants vs. fiber).
  • Ensuring packaging integrity maintains sterility barrier and desiccant function.

Validation & Performance Assurance

  • Accurately calculating required desiccant capacity/correct type for diverse products and climate conditions.
  • Demonstrating consistent and predictable adsorption performance across the product shelf life.
  • Validating performance under real-world conditions with complex protocols.

当社の乾燥剤を選ぶ理由

performance

Enhanced Regulatory Assurance

Our desiccants consistently meet and exceed stringent global standards (FDA, EMA, USP/EP) for purity, biocompatibility, and safety documentation.

checklist(1)

Superior Material Compatibility

Engineered to prevent contamination, corrosion, and interaction risks across all types (silica, chlorides, clays, fiber) with sensitive medical products.

シールド

Guaranteed Performance Reliability

Delivers predictable, high-efficiency moisture adsorption under diverse and extreme storage or transport conditions.

supply-chain-management

Comprehensive Supply Chain Support

Provides consistent quality, reliable availability, and technical expertise tailored to complex medical industry needs.

シールド

Optimized Safety & Cleanliness

Features minimized dusting, breakage, and leachables, ensuring physical and chemical safety for critical applications.

使用方法

Pharmaceutical Packaging (Vials, Blister Packs)

利用概要

Desiccants (primarily silica gel and molecular sieves) are integrated into pharmaceutical packaging to protect moisture-sensitive drugs, tablets, and capsules from degradation.

Pharmaceutical Packaging (Vials, Blister Packs)

主な利点

  • Stability Maintenance: Prevents hydrolysis and maintains chemical integrity of active pharmaceutical ingredients
  • Extended Shelf Life: Creates optimal low-humidity environments for hygroscopic medications
  • Regulatory Compliance: USP/EP-grade silica gel meets pharmacopeia standards for direct drug contact
  • Clean Operation: Non-dusting fiber desiccants prevent contamination in automated blister packing lines

Medical Device & Instrument Protection

利用概要

Montmorillonite, attapulgite, and silica gel canisters protect surgical tools, electronic equipment, and optical devices during sterilization, storage, and shipping.

Pharmaceutical Packaging (Vials, Blister Packs)

主な利点

  • Corrosion Prevention: Clay desiccants (montmorillonite/attapulgite) absorb moisture that causes metal instrument rust
  • Electronics Safeguarding: Silica gel protects sensitive circuitry in diagnostic machines from humidity damage
  • Physical Resilience: Non-friable formats resist breakage during device handling and transportation
  • Sterilization Compatibility: Desiccant packaging maintains integrity after gamma/ETO sterilization cycles

Diagnostic Reagent & Test Kit Preservation

利用概要

Silica gel and fiber desiccants preserve accuracy of diagnostic strips, reagents, and lateral flow test kits in hermetically sealed pouches.

Diagnostic Reagent & Test Kit Preservation

主な利点

  • Moisture-Sensitive Protection: Prevents premature activation of enzyme-based reagents
  • Low Particulate: Fiber desiccants eliminate dust interference with microfluidic test components
  • Uniform Performance: Provides consistent humidity control across varying temperature conditions
  • Compact Integration: Slim-profile sachets fit within small test kit packaging without compromising function

Implantables & Sterile Barrier Systems

利用概要

High-purity calcium chloride (CaCl₂), magnesium chloride (MgCl₂), and silica gel maintain dry environments in sterile barrier packaging for implants and single-use devices.

mplantables & Sterile Barrier Systems

主な利点

  • Biocompatibility Assurance: Ultra-pure chlorides prevent leachables in direct implant contact scenarios
  • High-Capacity Protection: Calcium chloride provides superior moisture absorption in long-term storage
  • Temperature Resilience: Magnesium chloride maintains adsorption efficiency at elevated temperatures
  • Sterility Maintenance: Compatible with all sterilization methods without generating endotoxins

よくあるご質問

包装・輸送用乾燥剤

シリカゲル乾燥剤は輸送や保管中の製品を保護するために必要なものです。シリカゲル乾燥剤は通気性のある小袋やキャニスターに包装され、輸送用コンテナ、カートン、木箱内の湿度を管理します。シリカゲルは周囲の空気中の水分を吸収し、結露、カビ、金属腐食、湿気に敏感な素材へのダメージを防ぎます。シリカゲルは、電子機器、機械、美術品、紙製品に最適で、世界的な輸送のロジスティクスの間にどのような気候の変化が起こったとしても、商品が正しい状態で到着することを保証します。

シリカゲルは、電子機器の製造や保管における調湿性能でよく知られています。特に、回路基板、半導体、光学機器などの包装では、繊細な部品を適切に保護することが重要です。シリカゲルを密閉パッケージや密閉キャビネットに使用することで、電子機器は低湿度環境に保たれます。これにより、酸化、電気的短絡、あらゆる種類の性能不良による部品への予期せぬ損傷のリスクを軽減することができます。シリカゲルの特性は、腐食性がなく、ホコリがなく、デリケートな部品に直接触れても安全であるため、工場から未開封の状態で安全に出荷され、取り扱われます。

シリカゲルは、薬瓶や診断キット、医療機器パッケージの構成要素として、重要な防湿機能を提供します。シリカゲルはFDAや薬局方の要件を満たし、錠剤やカプセル剤、実験用試薬を湿気による劣化や湿度上昇から保護します。重要なことは、シリカゲルは密閉された環境における湿度レベルを安定させ、保存期間、無菌性、治療効果や生存率を延ばす働きをするということです。シリカゲルパケットは湿度変化を滑らかにするだけでなく、透明なので目視検査も可能です。さらに、コバルトを含まないシリカゲルパケットは、意図的に敏感な用途においても毒性問題を引き起こしません。

シリカゲルは、薬瓶や診断キット、医療機器パッケージの構成要素として、重要な防湿機能を提供します。シリカゲルはFDAや薬局方の要件を満たし、錠剤やカプセル剤、実験用試薬を湿気による劣化や湿度上昇から保護します。重要なことは、シリカゲルは密閉された環境における湿度レベルを安定させ、保存期間、無菌性、治療効果や生存率を延ばす働きをするということです。シリカゲルパケットは湿度変化を滑らかにするだけでなく、透明なので目視検査も可能です。さらに、コバルトを含まないシリカゲルパケットは、意図的に敏感な用途においても毒性問題を引き起こしません。

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