The global biological sample shipping packaging market is booming, with the global sterile plastic bag market reaching 12.03 billion yuan in 2024 and expected to grow to 18.27 billion yuan by 2031 . As a professional exporter of UN3373-compliant biological sample packaging, Advance International Corp’s core product—95kPa specimen bags—has been helping global clients solve shipping pain points. Below, we combine real cases and industry data to show how our products stand out in the competitive market.

 

Global Market Boom Drives Demand for High-Quality Packaging

 

The biological sample transportation industry is experiencing robust growth driven by multiple factors:

 

• Market Scale Expansion: China’s medical specimen transportation container market reached 8.76 billion yuan in 2024, with exports soaring 18.7% year-on-year to 930 million US dollars . UN3373-compliant Category A packaging exports alone hit 180 million US dollars, mainly to Southeast Asia, the Middle East and Africa.

 

• Increased Application Scenarios: The expansion of third-party medical testing (market size exceeding 154 billion yuan in 2024) and the popularity of cross-regional clinical trials have boosted demand for compliant packaging .

 

• Stringent Regulatory Requirements: Countries worldwide are strengthening supervision over biological sample transportation, making UN3373 compliance a basic threshold for market access.

 

As a key player in this growth trend, our 95kPa specimen bags perfectly meet the dual needs of market expansion and regulatory compliance.

 

Solving Cross-Border Shipping Pain Points for a Southeast Asian Diagnostic Company

 

A leading diagnostic company in Indonesia faced critical challenges in transporting COVID-19 test samples to remote regions:

 

• High Leakage Rate: Their previous packaging had a 15% leakage rate during air transport, resulting in sample contamination and diagnostic delays.
• Regulatory Non-Compliance: Customs frequently detained shipments for failing UN3373 pressure resistance tests.
• Cost Losses: Annual losses due to packaging issues exceeded 200,000 US dollars.

 

After partnering with Advance International Corp, we provided a tailored solution based on our 95kPa specimen bags:

 

• Our bags passed the 95kPa pressure differential test required by IATA, ensuring no leakage during high-altitude transportation.
• The double-seal design enhanced leak-proof performance, and the sterile production process met BSL-2 laboratory standards.
• We optimized the packaging size to match their sample tubes, improving loading efficiency by 30%.

 

The results were remarkable:

 

• The client’s sample leakage rate dropped to 0% within three months.
• Customs clearance time was reduced from 3 days to 8 hours.
• Annual cost savings exceeded 150,000 US dollars. They have since signed a long-term contract, ordering 1.2 million bags annually.

 

 

Our 95kPa Specimen Bags: Core Advantages Backed by Data

 

Our products stand out in the market with three key strengths:

• Superior Compliance: 100% of our 95kPa bags meet UN3373 Category B standards and pass IATA’s strict pressure tests, ensuring smooth customs clearance in 90+ countries.

 

• Reliable Performance: With a puncture resistance of 15N and a seal strength 20% higher than industry averages, our bags maintain integrity even in harsh transportation conditions.

 

• Global Export Capability: We supply to 50+ countries, with Southeast Asia accounting for 40% of our exports—aligning with the region’s 19.6% annual growth in demand for compliant packaging .

 

We maintain strict quality control with a 0.01% defective rate, supported by our advanced production lines and ISO 13485 certification.

 

Future Trends: Green & Smart Upgrades for 95kPa Bags

 

The industry is evolving toward sustainability and intelligence, and we are at the forefront of these trends:

• Eco-Friendly Innovation: We are developing bio-based 95kPa bags using corn starch materials, responding to the global demand for green packaging that is expected to reach tens of billions of yuan in market size by 2025 .
• Smart Integration: Future products will incorporate temperature sensors to enable real-time monitoring, addressing the industry’s pain point of delayed temperature alerts .

 

As the global biological sample transportation market continues to grow, reliable packaging becomes increasingly critical. Advance International Corp’s 95kPa specimen bags combine compliance, performance, and cost-effectiveness to help clients succeed in global markets. For more information on our products and customized solutions, visit our website www.aicbiologicalbag.com today!

 

 

When the U.S. FDA announced its June 2025 ban on shipping U.S. clinical trial samples to “adversary nations” like China and Russia, the global biotech industry felt an immediate jolt. For U.S. biotechs, the loss of access to China’s high-throughput sequencing services—relied on by ~30% of U.S. clinical trials—threatened supply chain disruptions. For labs and manufacturers worldwide, it also raised the stakes: any clinical sample transport now demands stricter compliance, leak-proof safety, and global logistics resilience to avoid costly delays or regulatory penalties.

At AIC Biological Bag, we’ve built our solutions to address exactly these challenges. As a leading supplier of UN3373-compliant specimen transport bags and kits, we help biotech firms, clinical labs, and CROs (like your partners IQVIA and Labcorp) stay agile—even when policies shift. Below’s how the FDA ban is reshaping sample transport, and how AIC’s products keep your operations on track.

 

The FDA Ban’s Ripple Effect: What It Means for Global Sample Transport

 

The FDA’s policy reversal isn’t just a U.S.-China issue—it’s a wake-up call for the entire industry to prioritize two non-negotiables: regulatory compliance and supply chain reliability.

 

• Compliance Scrutiny Is Tighter Than Ever

With the FDA framing sample transport as a “national security” issue, customs and health authorities worldwide are stepping up inspections of cross-border shipments. Any sample bag that fails to meet international standards (like UN Regulation PI650 or UN3373 for biohazard materials) risks being held or rejected—delaying trials and wasting valuable specimens. 

 

For example, a U.S. biotech recently saw a batch of blood samples detained at a European port because their transport bags lacked 95kPa pressure certification, a key benchmark for leak resistance.

 

• Supply Chain Diversification Becomes Critical

The 30% reliance on China’s sequencing services has forced U.S. firms to seek alternative partners in regions like Southeast Asia or Europe. This shift means longer transport routes—and a greater need for durable, temperature-stable packaging that protects samples from turbulence, temperature fluctuations, or accidental drops. 

 

AIC’s clients in Singapore and Germany, for instance, now use our ai650 series for 72-hour transcontinental shipments, with zero leakage incidents.

 

• Risk Mitigation Is Non-Negotiable

The FDA’s lack of specific “violation examples” has left companies guessing about what qualifies as “high-risk” transport. To avoid gaps, labs and CROs are doubling down on safety features: absorbent pouches to contain spills, tamper-proof seals to prevent contamination, and independent document pockets to keep customs forms separate from samples. These aren’t just “nice-to-haves”—they’re essential for passing audits and maintaining trust with partners.

 

How AIC’s Solutions Address the FDA Ban’s Challenges

 

AIC’s product line—built around the 95kPa-certified ai650 series and UN3373-compliant accessories—directly solves the pain points of post-FDA-ban transport. Here’s how we support your operations:

 

1. UN-Certified Compliance: Pass Inspections Every Time

 

All AIC specimen transport bags (including the best-selling ai650 model L300420) are factory-tested to meet UN Regulation PI650 and UN3373 standards—the global gold standard for biohazard sample transport. Our 95kPa pressure certification ensures bags resist the physical stress of air cargo (turbulence, pressure changes) and accidental handling, eliminating the risk of leaks that could get shipments detained.

 

For U.S. firms shipping to alternative partners in Europe: Our bags align with EU 《Animal By-Product Regulation》 (EC 1069/2009), a common requirement for clinical sample imports.

 

For Chinese labs working with non-U.S. clients: Our compliance with IATA’s Dangerous Goods Regulations (DGR) ensures smooth clearance in 180+ countries.

 

2. Customized Kits for Diversified Supply Chains

 

The FDA ban has pushed companies to rethink their transport routes—and one-size-fits-all packaging no longer works. AIC’s customized kit assembly service lets you tailor solutions to your specific needs:

Small-batch shipments (e.g., 6*9inch blood sample bags for regional labs in Southeast Asia).

 

Large-volume trials (e.g., 7-slotted absorbent pouches (APS4X320) for UN 2814/2900 substances, used by our client Fortrea for cell therapy samples).

 

End-to-end logistics support: We leverage our Shanghai port proximity (3 hours by train from our Yangtze River Delta factory) to cut delivery times for global shipments—critical for time-sensitive clinical samples.

 

3. Trusted by Industry Leaders (Even Amid Uncertainty)

 

In times of policy chaos, partnering with a reliable supplier matters. AIC’s long-standing relationships with top CROs and biotechs—including Parexel, Labcorp, and ERGOMED—speak to our consistency. For example:

A U.S.-based biotech recently switched to AIC’s ai650 bags to ship samples to a new partner in South Korea. Their first 10 batches cleared customs in 48 hours, with no compliance issues.

 

A Chinese diagnostic lab used our absorbent pouches to safely transport COVID-19 test samples to Australia—meeting both WHO’s biohazard guidelines and local customs requirements.

 

Beyond the Ban: Building Long-Term Transport Resilience

 

The FDA’s 2025 policy isn’t just a temporary disruption—it’s a signal that global sample transport will only grow more complex. To stay ahead, biotech firms need partners who don’t just sell packaging, but offer end-to-end peace of mind:

AIC’s R&D team updates products quarterly to reflect new regulations (e.g., recent tweaks to our ai650 seal design to meet FDA’s latest “tamper-evident” guidelines).

Our after-sales team provides 24/7 support for customs questions—critical when shipping to new regions.

We offer OEM/ODM services to help you build branded, compliant kits that align with your global branding (e.g., custom document pockets with your lab’s logo).

Whether you’re a U.S. biotech diversifying your sequencing partners, a Chinese lab expanding to non-U.S. markets, or a CRO managing cross-border trials, AIC’s 95kPa-certified solutions keep your samples safe, compliant, and on time—no matter what policies come next.

 

Ready to future-proof your clinical sample transport? Contact our team today to design a customized kit for your next shipment. We ship to 50+ countries, with fast lead times and full compliance documentation included.

Why 95kPa Certification Is Non-Negotiable for Safe Biohazard Specimen Transport – AIC’s ai650 Series Has You Covered

For clinical labs, biotech firms, and hospitals, a single biohazard specimen leak during transit can mean $10k+ in wasted samples, delayed diagnostic reports, or even fines from regulators.

The first line of defense? A 95kPa pressure-certified transport bag that meets global safety standards. This is where AIC’s ai650 Series stands out.

 

What 95kPa Certification Actually Means for Your Specimens

 

Explain simply: 95kPa certification ensures the bag resists pressure equivalent to air cargo turbulence or accidental drops – no leakage, no tampering.

 

AIC’s ai650 (Model L300420) is factory-tested to 95kPa, compliant with UN Regulation PI650 for UN3373 biohazard materials (directly pull from your "Featured Products" section).

 

Beyond Pressure: The ai650 Series’ Hidden Safety Features

 

Super-strong adhesive seal: Prevents accidental opening during transit.

Independent document pocket: Keeps shipping forms separate from specimens (avoids contamination).

Matching absorbent pouches (APS4X320): Catches spills for UN 2814/2900/3373 substances – ideal for blood samples or diagnostic kits.

 

Global Compliance: How AIC Bags Fit Your International Shipping Needs

 

Address customer worry: "Will this bag pass EU/US customs?"

 

AIC’s ai650 meets UN3373, PI650, and aligns with IATA’s Dangerous Goods Regulations (DGR) – perfect for shipping to Europe, the US, or Southeast Asia (as mentioned in your "Latest News" about global collaboration).

 

Used by leading firms like IQVIA, Labcorp, and Parexel (from your "Partnership" section) – social proof builds credibility.

 

More Than a Bag: AIC’s End-to-End Support

 

Connect products to services: Customized kits (per "Customized kits, Anywhere in the world"), fast delivery (3-hour train to Shanghai port), and OEM/ODM options (from your "OEM & ODM" section).

Solve supply chain fears: Amid global raw material shortages, AIC’s Yangtze River Delta factory ensures stable stock (from "How Advance International Corp Secures Stable Supply").

 

Conclusion & Call to Action (CTA)

 

Safe, compliant specimen transport starts with the right bag – AIC’s 95kPa ai650 Series combines safety, compliance, and customization.

CTA: "Ready to protect your biohazard specimens? Contact our team today to discuss your customized transport solution – we ship worldwide."

In the critical field of biological specimen transportation, "selecting the correct packaging" serves as the primary line of defense to ensure sample integrity and regulatory compliance. Different scenarios present unique challenges: hospitals fear "wasting space with large bags, or insufficient space with small ones" for blood samples; clinical research demands stringent separation to prevent "cross-contamination" among multiple specimens; and international shipping risks "non-compliance detentions by customs."

 

To address the core needs of these diverse applications, AIC's specialized transport bag series, including the ai650, L300420, and APS4X320, are each strategically designed. This article will provide a precise needs-matching solution through a "Scenario-Based Selection Guide + Parameter Comparison + Customization Options," helping you accurately select models and avoid common pitfalls.

 

Scenario-Based Selection: Prioritize Transport Needs,Then Match the Model

 

1. Hospitals / Health Check Centers: Short-Haul Blood/Urine Specimen Transport — Prioritize "Small Size + High Transparency"

Core Needs: Small sample volume per trip (typically 1-2 test tubes), short transport distance (inter-departmental or intra-city), and the need for rapid specimen information verification (to avoid repeated opening of the package).

 

Recommended Model: 6x9 inch 95kPa Blood Specimen Transport Bag (A standard variant of the ai650 Series)

 

Why Choose This?

 

Optimal Size: The 6x9 inch (approx. 15 cm×23 cm) size perfectly accommodates 1-2 standard 5−10 ml blood collection tubes. The compact bag is lightweight, easily carried by medical staff, or fits into a care kit, preventing "oversized packaging" which can lead to sample agitation.

 

Material Advantage: Made from high-clarity Polyethylene (PE) material, it allows for visual verification of patient information and specimen ID on the tube label without opening the package, reducing the frequency of openings and minimizing contamination risks.

 

Basic Protection: Compliant with UN3373 and PI650 standards, its 95kPa pressure resistance handles common intra-city transit jolts (e.g., ambulance braking, elevator movement). Paired with a thin integrated absorbent layer, it can contain small amounts of condensation or minor accidental fluid leaks.

 

2.Clinical Research Institutions: Multi-Specimen / Multi-Site Transfer — Essential: "Compartmentalized Absorbent Bags"

Core Needs: Transportation of multiple specimens in a single shipment (e.g., 4-7 blood/CSF samples from different subjects), the requirement for strict segregation to prevent cross-contamination, and a robust defense against "leakage in the event of sample damage."

 

Recommended Model: APS4X320 4/7 Compartment Absorbent Bag (Used in conjunction with the ai650 Outer Packaging Bag)

 

 

Why Choose This?

 

Physical Segregation: The bag features 4 or 7 independent retention slots (card slots), each securing 1 test tube or small vial. This complete separation prevents tube collision during transport, thus avoiding label abrasion and specimen mixing.

 

Superior Absorption: The absorbent layer within the slots utilizes Superabsorbent Polymer (SAP), capable of absorbing up to 50 ml of liquid per slot (equivalent to the full volume of a standard test tube). Should a primary receptacle break due to impact, the leaked fluid is instantly immobilized, preventing wicking to other slots or the outer bag.

 

Broad Compatibility: It accommodates not only standard blood collection tubes but also 15 ml centrifuge tubes and 20 ml reagent vials, making it ideal for clinical studies requiring the "transfer of multiple specimen types in one batch."

 

3. International Biopharma / Cross-Border Labs: Long-Haul Air / Sea Freight — Essential: "Fully Compliant ai650 Series"

 

Core Needs: Passing UN3373 compliance checks by customs in regions like Europe, the Americas, and Southeast Asia; withstanding pressure changes during long-haul transport (e.g., high-altitude low-pressure environments in air freight); and ensuring long-term preservation of specimen labels and documentation.

 

Recommended Model: ai650 95kPa Certified Model (Can be paired with a separate Document Pouch)

 

 

Why Choose This?

 

Full Compliance: The bag is pre-printed with the UN3373 Biohazard Mark and the 95kPa Pressure Certification Seal. It comes with a manufacturer's Certificate of Compliance (ready for submission to customs). This simplifies adherence to international regulations such as the IATA DGR (Dangerous Goods Regulations) and US DOT rules, preventing delays or detentions due to "incomplete labeling."

 

Pressure and Stress Resistance: Subjected to simulated air transport pressure tests (repeated pressurization from −50 kPa to 95 kPa), the bag demonstrated no rupture or leakage. It is built to withstand the rigorous conditions of long-haul transportation, from China to Europe (approx. 12 hours air freight) or China to Southeast Asia (approx. 3 days sea freight).

 

Document Protection: Features a separate external document pouch for insertion of the specimen manifest, customs declaration forms, and test reports. This ensures the documentation is completely isolated from the specimens (preventing liquid contamination of documents) and the pouch uses waterproof material, protecting the paperwork even if the outer package encounters rain.

 

3 Steps to Quickly Identify the "Optimal Solution

 

Define the Scenario: First, clarify the nature of the transport: "Short-haul / Long-haul," "Single Specimen / Multiple Specimens," and "Standard / Special Environment" (e.g., cryogenic, radiation).

 

Match Parameters: Compare the scenario against the "Parameter Comparison Table," prioritizing "Regulatory Certification" and "Size" (e.g., international transport must check UN3373, multi-specimen transport must check the compartmentalized design).

 

Inquire About Customization: If standard models are insufficient (e.g., for extra-low temperature or large volume), directly contact the customization service to avoid using standard bags that introduce risk.

 

If you are still uncertain about the selection process, please contact the AIC Technical Team at www.aicbiologicalbag.com. Provide your specimen type and transportation details, and we will offer a complimentary "Selection Recommendation Report." You may also request free samples for testing, ensuring an accurate and risk-free choice.

From -80℃ Freezing to 60℃ Heat: Which Transport Bag to Choose for Different Biological Samples? (With Advance Selection Guide)​

 

Last week, we received an urgent inquiry from a research institute client: "Nearly a third of our transported blood samples suffered from hemolysis when they reached the lab, costing us half a month of experimental data!" Upon investigation, the issue traced back to the choice of transport bag—they had used ordinary PE bags, which could neither resist temperature fluctuations during transit nor provide anti-hemolysis protection.​

 

In biological sample transportation, "choosing the right bag" matters more than "choosing an expensive one." Different samples (blood, tissues, viral reagents) have entirely different temperature tolerances and biological characteristics, meaning their corresponding transport bags also vary significantly in material, layer count, and protective design. Today, we’ll share a practical selection guide using Advance’s core products (AI650 Bag, Lab Absorbent Pouches) to help you avoid sample loss.

 

I. Blood Samples: Anti-Hemolysis Is Critical—Ordinary PE Bags Are a No-Go!​

 

1. The "Temperature Dead Zone" for Blood Samples​

 

Blood samples (whole blood, serum, plasma) are extremely sensitive to temperature fluctuations:​

 

• During refrigerated storage (2-8℃), temperatures exceeding 10℃ accelerate red blood cell rupture; temperatures below 0℃ cause freezing, and ice crystals pierce cell membranes, directly leading to hemolysis.​

 

• Even for short-distance transport (4-6 hours), the temperature fluctuation range must not exceed ±2℃—otherwise, it will affect subsequent blood routine and biochemical test results.​

A previous client used ordinary PE bags to transport whole blood; a brief cold chain failure in the truck (temperature rose to 12℃) resulted in hemolysis of all 20 samples, causing tens of thousands of yuan in experimental losses.

2. Mandatory Material and Packaging Requirements​

 

• Preferred Material: Five-Layer Co-Extruded Film (Core Material of AI650 Bag)​

 

Ordinary PE bags have flaws: thin thickness (only 0.08mm), poor airtightness, easy oxygen permeation during temperature fluctuations, and potential leaching of trace additives that contaminate samples.​

In contrast, Advance’s AI650 Bag uses a five-layer co-extruded film (LDPE/Tie/EVOH/Tie/ULDPE). The inner layer is medical-grade ULDPE with a leaching rate of less than 0.01%, avoiding reactions with proteins in blood. The middle EVOH layer has an oxygen transmission rate of only 0.3cc/(m²·24h)—90% lower than ordinary PE bags—locking in a stable internal environment and fundamentally reducing hemolysis risks.​

 

For even better results, pair it with Advance’s Lab Absorbent Pouches. This absorbent bag quickly soaks up blood that may accidentally leak due to seal issues (water absorption capacity up to 15x its own weight), preventing cross-contamination of samples while keeping the bag interior dry to further minimize temperature-induced impacts on blood.​

 

• Packaging Layers: At Least Double Layers; "AI650 Bag + Outer Cushion Bag" 

 

Single-layer transport bags cannot withstand extrusion or vibration during transit. We recommend a double-layer structure: "inner AI650 Bag (for samples) + outer cushion bag (filled with bubble wrap)." In our tests, when whole blood-filled AI650 Bags were placed in cushion bags, the sample hemolysis rate was only 0.5% after a 1.2-meter drop test—far below the industry average of 3%.

 

3. Advance’s Test Data for Assurance​

 

• 72-hour refrigerated transport at 2-8℃: Temperature fluctuation inside the AI650 Bag ≤ ±1℃, sample hemolysis rate < 1%.​
• Accidental temperature rise to 30℃ (sustained for 2 hours): Thanks to the EVOH layer’s barrier, the internal temperature only rose to 12℃, not triggering the hemolysis threshold.

 

II. Tissue Samples: Low-Temperature Resistance + Puncture Protection—Even for -80℃ Freezing!​

 

1. The "Preservation Challenge" for Tissue Samples​

 

Tissue samples (e.g., tumor tissues, animal organs) typically require -80℃ freezing for preservation. During transport, it is necessary to maintain low temperatures and prevent sharp tissue edges from puncturing the bag. A client once used ordinary freezer bags to transport tumor tissues; the bag was pierced by tissue edges, and the sample deteriorated rapidly after exposure to air, forcing the experiment to be redone.​

 

2. "Dual Protection" for Materials and Packaging​

 

• Low-Temperature Resistant Material: AI650 Bag’s -196℃ Ultra-Low Temperature Tolerance​

 

Ordinary freezer bags become brittle at -80℃ and crack easily when folded. However, the five-layer co-extruded film of Advance’s AI650 Bag undergoes low-temperature toughness treatment, remaining flexible even at -196℃ (liquid nitrogen temperature) with unchanged sealing performance after repeated folding.​

 

For tissue samples that may leak bodily fluids, pairing with Lab Absorbent Pouches creates "dual protection": the absorbent bag soaks up leaked fluids, preventing them from freezing and puncturing the transport bag. Our clients report that this combination reduces tissue sample transport loss rates from 8% to below 1%.​

 

• Packaging Layers: Three-Layer Protection for Extreme Transport Conditions​

 

A three-layer structure is recommended: "inner AI650 Bag (for tissue samples) + middle Lab Absorbent Pouches (absorbent protection) + outer rigid carton (anti-extrusion)." Especially for frozen tissue transport, dry ice can be placed inside the carton. The AI650 Bag’s low-temperature resistance ensures samples are not damaged by freezing, while the outer carton prevents deformation caused by dry ice sublimation.​

 

3. Advance’s Test Data for Assurance​

 

After 72 hours of freezing at -80℃: The AI650 Bag maintains a 99.8% sealing rate. When the bag is opened, the tissue sample remains intact in shape with no freezing damage or deterioration.​

Puncture resistance test: Pressing a sharp tissue edge (5mm diameter) against the AI650 Bag (50N pressure) for 10 minutes resulted in no damage or leakage.

 

III. Viral Reagents: Biosafety First, with Temperature Stability as a Priority​

 

1. "Dual Risks" of Viral Reagents​

 

Viral reagents (e.g., COVID-19, influenza virus samples) are not only temperature-sensitive (most require -20℃ freezing or 2-8℃ refrigeration) but also pose biosafety risks. If the transport bag is damaged, viral leakage could trigger public safety issues. Thus, compliance with UN Class 6.2 Dangerous Goods Transport Standards is mandatory.​

 

2. "Compliant Design" for Materials and Packaging​

 

• Compliant Material: AI650 Bag Certified by IATA DGR​

 

Ordinary transport bags cannot meet the sealing requirements for dangerous goods transport. However, Advance’s AI650 Bag has passed the International Air Transport Association (IATA) Dangerous Goods Regulations (DGR) Edition 63 certification. Its double-seal design achieves 0 leakage, fully complying with biosafety transport standards for viral reagents.​

 

Meanwhile, the absorbent layer of Lab Absorbent Pouches undergoes antibacterial treatment. Even if viral reagents accidentally leak, the antibacterial components in the absorbent bag inhibit viral activity and reduce spread risks—critical for cross-border transport (e.g., meeting EU IVDR regulatory biosafety requirements for exports).​

 

• Packaging Layers: Designed by Hazard Level, At Least Three Layers​

 

Packaging layers should be adjusted based on the risk level of viral reagents:​

Low-risk viruses (e.g., ordinary influenza viruses): "AI650 Bag + Lab Absorbent Pouches + outer waterproof bag."​

High-risk viruses (e.g., COVID-19): Add an outer rigid carton with biohazard labels to the above structure. The carton must pass a 1.2-meter multi-directional drop test (Advance’s custom cartons meet this requirement).​

 

3. Advance’s Test Data for Assurance​

 

96-hour refrigerated transport at 2-8℃: The activity retention rate of viral reagents inside the AI650 Bag reaches 95%—far higher than the industry average of 85%.​

 

Biosafety test: Simulating a transport bag damage scenario, Lab Absorbent Pouches absorb all leaked reagents within 30 seconds, with an antibacterial rate of 99% and no viral spread risks.

 

 

 

Is Your Sample Transport Still "Trial and Error"?​

 

If your team is struggling with blood sample hemolysis, tissue sample freezing damage, or compliant transport of viral reagents, click here to visit www.aicbiologicalbag.com. Get a custom selection plan from Advance—we’ll recommend the most suitable AI650 Bag combination based on your sample type, transport distance, and temperature requirements. You can also request free samples for testing, ensuring "zero loss" in biological sample transport!

 

I. (Core Value: Unparalleled Diagnostic Capability

High-resolution, non-invasive “optical biopsy”

Traditionally, to make a clear diagnosis of many diseases, a biopsy was required, which involves taking a small piece of tissue and observing it under a microscope. This is an invasive operation.

OCT provides cross-sectional images similar to biopsies, but it is completely contactless and non-invasive. Doctors can directly observe the microstructure of the surface and subsurface layers of tissues inside the body without the need for cutting, significantly reducing risks and patient discomfort.



2. Real-time imaging, guiding treatment

OCT imaging is extremely fast and can provide images in real time. This enables doctors to immediately assess the condition of the tissue during surgery or interventional treatment, thereby making more accurate decisions.

For instance, during cardiovascular interventional surgery, doctors can view in real time the nature of the plaques within the blood vessels and the adhesion of stents.



Ii. (Main Application Fields and Specific Assistance）

The application of OCT has expanded from ophthalmology to multiple medical fields. Here are some of its most important applications:

Ophthalmology - the most mature and widely applied field

This is a prime example of the success story of OCT technology, which has completely transformed the diagnosis and treatment of retinal diseases.

Help

Diagnosis of macular diseases: Precise diagnosis and staging of age-related macular degeneration (AMD), macular edema, macular holes and other diseases is the gold standard.

Glaucoma management: By precisely measuring the thickness of the retinal nerve fiber layer (RNFL), early diagnosis of glaucoma and objective monitoring of disease progression can be achieved.

Diabetic retinopathy: Early detection of subtle changes and edema in the retina to guide treatment.

Impact on the industry: It has led ophthalmic diagnosis from subjective two-dimensional fundus photography to an era of objective and quantitative three-dimensional microstructure analysis.



2. Cardiology - A rapidly developing frontier field

Intravascular OCT (IV-OCT) enters the interior of blood vessels through slender catheters for imaging.

Help

Precise assessment of plaques: Clearly distinguish lipid plaques, fibrous plaques and calcified plaques, and identify easily ruptured “vulnerable plaques”, which is something that traditional angiography cannot achieve.

Optimizing stent implantation: During percutaneous coronary intervention (PCI), guiding doctors to select stents of appropriate size and accurately assessing whether the stents are fully adhered and sufficiently dilated after the operation significantly reduces the risk of restenosis and thrombosis after the operation.

Impact on the industry: It has advanced coronary intervention therapy from the era of “walking according to the route map” with angiography to the era of “navigating with a high-brightness map on” with precision.



3. Combination of oncology and endoscopy

Integrating the OCT probe into the endoscope enables deep scanning of suspicious areas simultaneously during endoscopic examinations of the digestive tract, respiratory tract, etc.

Help

Early cancer diagnosis: In the gastrointestinal tract, respiratory tract, bladder and other areas, distinguish benign lesions from early cancer, guide the biopsy location, and increase the positive rate of biopsy.

Determine the tumor boundary: Assist surgeons in determining the precise boundary of the tumor during surgery to ensure complete resection while preserving as much healthy tissue as possible.

Impact on the industry: It has enhanced the depth and accuracy of endoscopic examinations and promoted the screening and diagnosis capabilities for early-stage tumors.



4. Dermatology

Skin OCT is similar to ophthalmic OCT and can perform high-resolution imaging of the skin’s surface layer.

Help

Non-invasive diagnosis: It assists in the diagnosis of skin tumors such as basal cell carcinoma and melanoma, as well as inflammatory diseases like eczema and psoriasis.

Treatment monitoring: Non-invasive monitoring of the efficacy of drug treatment or laser treatment.

Impact on the industry: It has reduced the need for some diagnostic biopsies and provided new tools for the dynamic monitoring of skin diseases.



Iii. (Summary of the Overall Impact on the Healthcare Industry)

1. Enhance the level of diagnosis and treatment: Early diagnosis, precise staging and personalized treatment of diseases have been achieved.
   
   
2. Enhance patient experience: Through non-invasive or minimally invasive examinations, patients’ pain, risk of complications and recovery time are reduced.
   
   
3. Reduce medical costs: Although OCT devices themselves are expensive, they can lower overall medical expenses in the long run by avoiding unnecessary surgeries, optimizing the treatment process and reducing complications.
   
   
4. Promoting scientific research development: It provides powerful in vivo imaging tools for medical research, accelerating the development of new drugs and in-depth understanding of disease pathological mechanisms.
   
   
   

The first step: Demarcate the boundaries of the “safe” and the environment (regional boundary security)
OCT devices

should not be directly exposed to public networks. First, it is necessary to plan the security domain.

1. Network partition isolation
   
   Medical equipment dedicated network: OCT devices, PACS servers, image storage servers, etc. are classified into an independent VLAN and logically isolated from the office network and the Internet.
   
   Firewall policy: Deploy firewalls at the network boundary and strictly follow the “principle of least privilege”. Only specific and necessary ports and IP addresses are allowed for communication (for example, port 104 of the DICOM protocol, a specific port of the hospital information system). Any illegal external access is prohibited.
   
2. Physical Access Control
   
   The computer room where OCT equipment and core servers are placed should implement strict physical access control and video surveillance management to prevent unauthorized physical contact.
   
   Step 2: Build a sturdy box for the "safe" (secure computing environment)
   This is the core layer that protects the data itself.
   OCT Equipment and Terminal Security:
   Strengthen the operating system: Enhance the security of the operating system of the industrial control computer or computer built into the OCT device, as well as that of the diagnostic workstation.
   Anti-virus software: Install hospital-specific anti-virus software and update the virus database regularly.
   Identity authentication: It is mandatory to log in to the system with a unique personal username and a strong password. For the third-level information security protection, two-factor authentication should be mandatory.
   
3. Data storage encryption (lock of the safe) :
   
   Static data encryption: All OCT image data must be encrypted when stored on the disk. Available options:
   
   Transparent database encryption: Encrypting sensitive fields in the database.
   
   Storage layer encryption: Encrypt the entire disk or volume using the built-in encryption function of the storage device or operating system-level encryption.
   
   File-level encryption: Encrypting a single DICOM file.
   
   Key management: Encryption keys must be uniformly managed by a professional key management system, stored separately from encrypted data, and rotated regularly. This is the key point of the requirements for the equal protection.
   
4. Application Security
   
   Ensure that the PACS software and OCT device software themselves have no known high-risk vulnerabilities, and conduct regular security assessments.
   
   Step 3: Ensure "safety during transportation" (communication network security)
   When data is transmitted between OCT devices, PACS servers and diagnostic workstations, it is necessary to prevent eavesdropping and tampering.
   
5. Transmission encryption
   
   Enforce the use of encryption protocols such as DICOM over TLS or DICOM over HTTPS to replace the traditional plaintext DICOM protocol. This ensures that data is encrypted when transmitted over the network, similar to HTTPS protecting web page communication.
   
   For scenarios such as remote consultation that require cross-internet transmission, a VPN encrypted tunnel must be established.
   
   Step 4: Establish a monitoring and management center for the "safe deposit box" (Safety Management center)
   This is the brain and nerve center of the "safe", responsible for monitoring, auditing and emergency response.
   
6. Log audit (recording who opened the box) :
   
   Collect all logs related to OCT data centrally, including: user login/logout logs, logs of OCT image creation, modification, deletion, access, printing, export and other operations. These logs must be retained for no less than six months.
   
   The information security protection level requires that the content of logs cannot be tampered with, so it is necessary to deploy a professional log auditing system.
   
7. Database Audit
   
   For operations that directly access the database, a database auditing system is deployed to record all access behaviors to OCT data tables, especially high-risk operations.
   
8. Operation and Maintenance Management and Security Audit
   
   Video the operations of system administrators and record instructions to achieve traceability.
   
   Regularly conduct security risk assessments and vulnerability scans.
   
9. Data Backup and Recovery (Spare key for the safe) :
   
   Formulate a complete data backup strategy and regularly back up OCT image data and related patient information.
   
   Regularly conduct disaster recovery drills to ensure that business and data can be quickly restored in the event of data loss, system downtime or ransomware attacks. Backup data also needs to be encrypted for protection.
   

   
   

   
   

   Also welcome to contact us, we are ZD Medical Inc.
   Tel : +86-187 9586 9515
   Email : sales@zd-med.com
   Whatsapp/Mobile : +86-187 9586 9515