1) Market Structure and Volume (Two tracks)

A. Sterilization container system (Rigid Sterilization Containers)

As the core infrastructure of the hospital CSSD sterilization and turnover system, the global market size is approximately 355 to 386 million US dollars in 2023-2024, and it is expected to have a CAGR of about 4.6% to 6.1% by 2030-2032. The main material is aluminum/stainless steel, and it is iterated around the filter/valve structure and traceable accessories.

B. Transport & Protection Cases for surgical/medical equipment "storage bags"

The scenarios cover inter-departmental transfer within the hospital, carrying by service engineers outside the hospital, distribution/clinical demonstration kits, etc. The forms include EVA hot-pressed hard shells, soft sewing bags, injection molded/aluminum boxes, etc. The selling points are mainly focused on shock protection, die-cut inner shells, accessory compartments, lightweight and brand display. This type does not directly assume the responsibility of a sterile barrier, but it needs to be combined with sterilization packaging and standardized procedures.

Key division of labor: Sterilization containers are responsible for maintaining sterility (CSSD). Storage/carrying bags are responsible for turnover protection and image/functional expansion. The compliance standards for the two are different.

2) Key points and boundaries of compliance

General Guidelines for Hospital Steam Sterilization (AAMI ST79) : Comprehensive Guidelines for Steam Sterilization and Aseptic Maintenance in Medical Institutions; It is strongly related to the equipment tray/container/packaging process. If the storage bag does not enter the sterilization process, it does not assume the aseptic barrier responsibility as described in ST79.

Sterile barriers and terminal sterilization packaging (ISO 11607-1) : Defining performance and testing requirements for materials, preforms and packaging systems; If storage bags are only used for transportation protection and cannot replace the "sterile barrier" in the sense of ISO 11607, they should be used in conjunction with sterilization bags/non-woven fabrics or rigid containers.

Moist heat sterilization process (ISO 17665:2024) : It sets requirements for the development, validation and daily control of sterilization processes. Once again, it is emphasized that the carriers and packaging entering the sterilization process must be verifiable and compliant.

Medical device supplier management (ISO 13485 Supplier Control) : Complete machine manufacturers need to establish evaluation, monitoring and change control for outsourced components/auxiliary materials (including carrying bags) to ensure regulatory consistency and traceability.

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3) Mainstream product forms (storage/carrying bags)

EVA hot-pressed hard shell: Lightweight and pressure-resistant, the inner liner is combined with EVA/CNC die-cutting and the upper cover mesh bag, suitable for instrument trays, handles, pipelines, probes, etc. Supports Logo/ color schemes and label Windows.

Soft sewing/composite structure: nylon/polyester /TPU composite fabric, shock-absorbing foam layer +PP board support; Expandable shoulder straps/rollers with document bags.

Engineer Service Box/Demonstration Box: Injection molded/aluminum frame + custom inner lining, emphasizing durability, lockability and modular accessory compartment.

4) Industry Trends (2025-2027)

From "single-machine protection" to "complete solution" : The package body + pallet + label + document management in a packaged and workstation-based manner reduces transportation errors.

Lightweight and ergonomics: EVA/ sandwich panels replace heavy metal boxes, optimizing the grip point and shoulder strap system; Adapt to high-frequency transportation in hospitals and accompanying people outside the hospital.

Traceability and identification: External barcode /RFID Windows, consumable number areas and equipment list inserts enhance SPD/ warehouse and distribution efficiency (complementary to the traceability requirements of ISO 13485).

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Compliance and transparency: Although not a sterile barrier, leading suppliers will proactively provide material reports, REACH/RoHS, and compatibility instructions for cleaning and disinfection to meet the requirements of terminal registration and auditing.

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5) Opportunity window

"Misaligned synergy" with the sterilization system: Focusing on preoperative preparation kits/specialized instrument kits, out-of-hospital maintenance portable kits, and clinical demonstration kits outside of CSSD, avoiding the red ocean of rigid containers, and creating value with "efficiency + image".

Scenario-based module: The inner tank adopts replaceable modules/Velcro partitions, allowing for quick switching between different equipment combinations and reducing SKU and inventory.

High-reliability materials and cleanable design: Outer layer resistant to wiping and disinfection (alcohol/quaternary ammonium salt/peroxide), detachable inner lining, hidden stitching and dust-proof zipper, with identification window and IP water resistance rating description. (Extended by integrating hospital cleaning procedures with the best practices of suppliers)

Brand/Display attributes: A demonstration set for clinical education/academic promotion, emphasizing appearance, structure, storage logic and information presentation, enhancing the "overall feel" of the device.

6) Challenges and Responses

Unclear compliance boundaries: The mixed use of storage bags and aseptic barrier concepts can easily lead to risks - Solution: Clearly define the uses and limitations in the technical documentation, and make boundary declarations by referring to ISO 11607/ISO 17665/AAMI ST79.

Homogenization and price pressure: Fierce competition between EVA and soft packaging - Response: Develop structural patents/appearance designs, universal modules for inner tanks and rapid small-batch customization, and bind to department/brand scenarios.

Medical customer Audit: Supplier Evaluation and change Control Tightened under ISO 13485 - Response: Establish incoming material/process/finished product records and batch traceability, and maintain compliance files for key materials.

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7) Supply-side representative and your company's positioning

Dongguan Chfine Luggages And Cases Co., Ltd

As a manufacturer of EVA and custom carrying bags, we have the production capacity of hot pressing /EVA die-cutting/sewing composite and brand customization experience. Public information shows that it has long-term supply and large-scale capacity for medical and electronic EVA bags (such as factory area, personnel and daily production capacity, etc.), and remains active on Alibaba International Station. For medical clients, we can provide services such as the design of packaged inner containers for medical devices, identification Windows/label holders, compliance material explanations, and small-batch sampling.

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Suggestions for Cooperation Implementation (for Chfine and Medical Clients)

Usage statement: Mark "Non-sterile barrier, do not enter sterilization process" in the instruction manual/compliance document, and provide a recommended list of cleaning/disinfection compatibility.

Modular inner liner library: Focusing on high-frequency instruments such as general surgery, orthopedics, and endoscopy, it accumulates universal inner liner mold pieces and partition parts to shorten the development cycle of new cases.

Traceability support: Standardized label Windows /RFID pockets/device list inserts, connecting hospital SPDS with distribution warehouses.

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Audit preparation: Establish RoHS/REACH compatibility declarations with cleaning and disinfection for key materials; Provide change and batch records in accordance with ISO 13485 supplier management requirements.

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8) Conclusion (One sentence)

Give way to rigid sterilization containers for "sterile maintenance" and take "portability and efficiency" to the extreme - with the lightness and modularity of EVA/ soft packaging, create a premium around the scenarios of instrument sets, traceability, display and service. Only by clarifying the boundaries and evidence in the terms of ISO 11607/17665/AAMI ST79 and ISO 13485 can the volume be steadily increased in the medical channel.