Lembar Es Kering yang Disetujui FDA untuk Insulin – Aman 2025 Memandu

Transporting insulin across cities, countries or just on a long weekend trip isn’t as simple as throwing it into a cooler. Insulin loses potency when it freezes or overheats, yet ordinary ice melts quickly and can leak. FDA approved dry ice sheets for insulin sound like the perfect solution, but the term is often misunderstood. Pada kenyataannya, dry ice is solid carbon dioxide at –78.5 °C (–109 ° F.), and contact with it can freeze insulin. This guide explains what “FDAapproved” really means for dry ice packaging, Kapan (and when not) to use dry ice sheets, and how to build a safe packout to keep your insulin between 2 °C dan 8 ° C..

What does FDA approval mean for dry ice sheets? Learn about FDA regulations for packaging materials and why the CO₂ itself isn’t “disetujui”.

Are dry ice sheets safe for insulin? Understand why direct contact with –78 °C dry ice can damage insulin and how to buffer extreme cold.

How do you build a safe packout? Stepbystep instructions for layering phasechange materials (PCMS), insulation and dry ice.

Berapa banyak es kering yang harus Anda gunakan? Use formulas and sizing rules to calculate the right amount and avoid freezing.

What are the regulations? Know the 2.5 kg airline limit, labeling rules and packaging requirements.

Apa tren terkini? Mengeksplorasi 2025 inovasi dalam logistik rantai dingin, biodegradable packaging and IoT monitoring.

Are FDA Approved Dry Ice Sheets Safe for Insulin?

Jawaban Langsung: Dry ice sheets are not inherently “FDA approved,” and they are rarely safe for insulin by themselves. Dry ice sits at –78 °C and can freeze and denature insulin if it comes into direct contact. The FDA doesn’t actually approve the carbondioxide ice; instead it regulates the bahan pengemasan that may contact food or drugs. For insulin, which must stay between 2 °C dan 8 °C to maintain potency, using dry ice requires a buffer layer such as phasechange material (PCM) bricks set to +5 ° C., otherwise the extreme cold will ruin the medicine.

Penjelasan: memahami “FDA approval” for dry ice sheets

When marketing describes “FDA approved dry ice sheets,” it usually refers to the packaging films, gels and adhesives that wrap or accompany the dry ice, not the CO₂ itself. AS. Administrasi Makanan dan Obat -obatan (FDA) treats any substance intended to contact food or pharmaceuticals as a foodcontact material. Manufacturers must submit data through the Food Contact Notification (FCN) proses showing that chemicals won’t migrate into foods at unsafe levels. Untuk paket es kering, kepatuhan biasanya melibatkan:

Outer films: Polietilen densitas tinggi (HDPE) atau polypropylene (Pp) films that are inert and resist chemical migration. These plastics protect your insulin from contamination and are sturdy enough for cold conditions.

Refrigerant gels: Foodgrade superabsorbent polymers that absorb water and freeze into a viscous mass. They must be nontoxic and formulated to prevent chemical leaching when frozen and thawed.

Sealant dan perekat: Foodsafe hotmelt adhesives create leakproof seals.

Label: UN1845 hazard labels warn handlers that carbondioxide (es kering) is inside.

Karena itu, an FDA compliant dry ice sheet for insulin must use foodsafe plastics and gels, but the CO₂ inside will still sit at –78 °C. Without proper buffering, insulin will freeze and crystallize.

Meja 1: Components of an FDA compliant dry ice sheet and their benefits

Tips dan saran praktis

Verifikasi dokumentasi: Always request an FDA compliance certificate from your supplier. Without proof, you risk using materials that may leach chemicals into your medicine.

Never let dry ice touch insulin: Even with FDA compliant packaging, you must separate insulin from dry ice. Menggunakan +5 °C PCM bricks or gel packs as a buffer.

Beri label dengan jelas: Mark packages with “Contains Dry Ice” and the net weight of dry ice, as required by DOT/IATA.

Ask for insulation quality: When ordering, confirm that the outer film thickness matches your coldchain duration and ambient conditions.

Contoh kasus: A seafood company switched to polyethylene wrapped dry ice packs after learning that some generic packs used recycled plastics with unknown additives. By verifying FDA compliance and adding a cardboard barrier between the ice and their product, they eliminated customer complaints of offflavors.

How to Package Insulin with Dry Ice Sheets Properly

Keeping insulin cold without freezing is like balancing on a tightrope. Dry ice provides ultracold temperatures for frozen vaccines but will freeze insulin without a protective buffer. The safe solution is to build a layered packout using phasechange materials, isolasi dan wadah berventilasi.

Stepbystep: Building a safe packout

Precondition your PCM: Tempat +5 °C PCM bricks or gel packs in the refrigerator for at least 24 hours to stabilize them at 2–8 °C. Do not put them in the freezer, as they could become too cold.

Siapkan insulinnya: Put insulin pens or vials in a rigid plastic or metal case to prevent crushing and provide structural support.

Layer with PCM: Wrap the insulin case with PCM bricks on all sides, leaving a 1–2 cm buffer between the insulin and any subzero element. This creates a thermal “sandwich” that keeps temperatures in the safe 2–8 °C range.

Tambahkan isolasi: Use highquality insulation like expanded polystyrene (EPS), Polypropylene yang diperluas (EPP) atau panel terisolasi vakum (VIP) untuk memperlambat perpindahan panas.

Tempatkan es kering: Put dry ice sheets or blocks outside the PCM layer in the outer compartment of your cooler. Leave room for gas to escape and never seal the container airtight. Es kering sublimat ke dalam gas co₂; a sealed container can explode.

Beri label dan beri ventilasi: Mark the container with “DRY ICE / KARBON DIOKSIDA, SOLID” dan berat bersih, and ensure the lid has vents or holes for gas release.

Pantau suhunya: Place a temperature data logger near the insulin compartment. Setel alarm pada 2 °C dan 8 °C with a delay (sekitar 10 menit) for handling events. Checking the log ensures your packout stayed within range throughout the journey.

Kasus aktual: A remote clinic sent insulin vials to a rural area by layering +5 °C PCM bricks inside a VIPlined container. Mereka ditempatkan 0.8 kg of dry ice in the outer compartment and vented the box. The logger recorded temperatures between 3.5 °C dan 6 °C over 48 jam, meeting regulatory requirements and preventing freeze damage.

Meja 2: Packout steps, recommended conditions and benefits

Practical tips for common scenarios

Perjalanan singkat (≤18 hours, mild climate ≤25 °C): Lewati es kering. PCM bricks alone can maintain 2–8 °C. Dua +5 °C PCM bricks in an insulated case are sufficient.

Moderate journey (25–32 °C, 18–36 jam): Add extra insulation and an extra PCM brick. Hanya gunakan 0–0.5 kg/day of dry ice if ambient temperature is high.

Hot climate (≥32 °C) or multiday trip (>36 jam): Gunakan a buffered dry ice packout. Add four or more +5 °C batu bata PCM dan 0.5–0.8 kg of dry ice per day. Always keep dry ice outside the PCM layer to prevent freezing.

Ask yourself five questions: Berapa lama perjalanan Anda? What’s the peak temperature? How many pens or vials? Apakah Anda akan tanpa pendingin? Do airline rules permit dry ice on your route? Answering these determines whether you need dry ice.

Preweight and label: Airlines typically allow hingga 2.5 kg (5.5 lb) es kering per penumpang. Mark the net weight on the label and ensure ventilation.

Conduct a trial run: Perform a 12–24 hour test with a temperature logger before your actual trip to verify that your packout maintains 2–8 °C.

Managing the amount of dry ice

Es kering menyublim pada suhu sekitar 5–10 pon (2.27–4,54kg) per 24 jam. To estimate how much you need, multiply your cooler’s volume by the temperature difference and factor in transit time. A simple formula used by logistics experts is:

(volume yang lebih dingin × celah suhu × 0.12) ÷ 150 × 1.25

Misalnya, A 100 L container traveling from 25 °C to –70 °C requires ~9.5 kg of dry ice. If your insulin trip is shorter and only requires 0 ° C ke +5 ° C., you’ll need far less; a small cooler for a weekend trip may only use 0.5–1 kg of dry ice with proper PCM buffering. Remember that airlines limit each passenger to 2.5 kg, so adjust accordingly and consider splitting shipments or adding gel packs.

Pertimbangan Peraturan dan Keamanan

Shipping with dry ice involves more than just packing; you must comply with several regulations and safety guidelines.

Persyaratan pengemasan dan ventilasi

Ventilasi gas: Packages containing dry ice must allow carbondioxide gas to escape. Dry ice must never be sealed in an airtight container.

Integritas paket: The package must be strong enough to withstand normal handling and prevent any loss of contents due to vibration, temperature or altitude changes.

Pemilihan materi: Hindari plastik yang menjadi rapuh pada suhu rendah; use commercially available dryice packaging intended for extreme cold.

Menandai dan memberi label: Each package must be marked with “Carbon dioxide, padat” atau “Es Kering”, the shipper’s and recipient’s name and address, dan net quantity of dry ice. The outermost container must carry a kelas bahaya 9 label dan nomor PBB 1845.

Batasan berat badan: The maximum allowable net quantity of dry ice in a package is 200 kg for commercial cargo, but airlines and the FAA limit passengers to 2.5 kg (5.5 lb) per package and per passenger. Always check with your carrier.

FAA and DOT rules for passenger travel

Administrasi Penerbangan Federal (FAA) classifies dry ice as a bahan berbahaya. Passengers may carry dry ice in baggage only with airline approval. The FAA requires that:

The package must not be airtight and must allow CO₂ to vent.

The package must be labeled “Dry ice” or “Carbon dioxide, solid” and show the berat bersih es kering or state that it’s 2.5 kg or less.

Peraturan pengemasan farmasi

Di bawah 21 CFR 211.94(B), container closure systems for pharmaceuticals must protect against foreseeable external factors that can cause deterioration or contamination. Untuk pengiriman insulin, kemasan rangkap tiga sering kali diperlukan: sebuah wadah utama (botol atau pena), a secondary packaging (kasus yang kaku), dan paket berinsulasi luar dengan es kering. The Parenteral Drug Association (PDA) and ASTM also publish standards for thermal packaging tests.

Tip keselamatan untuk menangani es kering

Kenakan perlengkapan pelindung: Es kering dapat menyebabkan radang dingin. Kenakan sarung tangan terisolasi, kacamata dan celemek saat menangani.

Hindari penyimpanan kedap udara: Never store dry ice in glass or sealed containers; sublimasi dapat menyebabkan peningkatan tekanan dan ledakan.

Pisahkan isinya: Keep insulin or other products separate from dry ice; its only purpose is to keep the system cold.

Calculate sublimation rate: Mengharapkan 5–10 lb of dry ice to sublimate every 24 jam and factor in an extra day for delays.

Lengkapi dengan paket gel: Menggabungkan es kering dengan frozen gel packs can reduce the amount of dry ice needed and mitigate extreme cold.

Alternatives to Dry Ice Sheets for Insulin

Dry ice isn’t always the best or safest choice for insulin. Alternatives like gel packs and phasechange materials often keep insulin within the safe range without complicated regulations.

Gel packs and PCM bricks

Gel packs are pouches filled with nontoxic, foodgrade gels that freeze at around 0–4 °C and remain flexible. Medicalgrade gel packs can maintain refrigerated temperatures up to 33 hours and roomtemperature hold times over 52 jam. Bahan perubahan fase (PCM) batu bata engineered to melt at +5 °C provide precise temperature control for 24–48 hours and can be reused thousands of times. Both options avoid the need for vented packaging and hazardous material labeling.

Hydrogel evaporative packs use crystals that absorb water and slowly evaporate, keeping contents around +20 ° C untuk 45 jam. They are lightweight and convenient for outdoor travel or roomtemperature insulin but cannot maintain refrigerated conditions.

Advantages of gel packs and PCMs (sekilas)

Tips for using alternatives

Opt for PCMs for long trips: PCM bricks preconditioned to +5 °C offer tight control and are safe for insulin. They’re easy to reuse and avoid hazardous classification.

Gabungkan paket gel dengan insulasi: Untuk penerbangan pendek, one gel pack may suffice, but adding an insulated sleeve or reflective foil can double the hold time.

Hidrasi paket evaporatif dengan benar: Soak hydrogel packs in clean water for the recommended time, then blot off excess moisture before placing them in your travel kit.

Store and reuse gel packs correctly: Refreeze gel packs flat for 24 hours before each trip; periksa kebocoran; rotate packs and mark the date and number of uses.

2025 Tren dan Inovasi dalam Logistik Rantai Dingin

Industri rantai dingin berkembang pesat. Supply constraints, sustainability pressures and new technologies are reshaping how companies transport temperaturesensitive products.

Dinamika pasar

The global dryice market is growing despite headwinds. Demand has been climbing around 5 % per tahun, sementara pasokan CO₂ hanya meningkat 0.5 %, menyebabkan kelangkaan berkala dan ketidakstabilan harga. Spot prices have surged by up to 300 % selama krisis pasokan. Meskipun demikian, pasar dihargai USD 1.54 miliar masuk 2024 dan diproyeksikan untuk mencapai USD 2.73 miliar oleh 2032 (compound annual growth rate ~7.4 %). Growth is fueled by rising demand for biologics, mRNA vaccines and frozen food delivery.

Dry ice formats and performance

Not all dry ice is equal. Large blocks or slabs sublimate slowly and are ideal for bulk shipments or long durations. Pelet dan nugget, with more surface area, memberikan pendinginan yang cepat tetapi menguap lebih cepat, making them suitable for prechilling or short hauls. Thin slices or custom cuts balance coverage and duration, fitting neatly into packaging systems to reduce voids. Choosing the wrong format can compromise product integrity—small pellets may supercool pharma payloads if not properly vented, while large blocks may be too slow for fast ecommerce shipments.

Packaging and insulation innovations

Thermal performance depends as much on desain kontainer as on the ice itself. Poorly designed containers accelerate sublimation; optimized insulation can stretch hold times significantly. Key factors include preconditioning containers before loading, meminimalkan ruang kosong, and arranging the dry ice above the payload so cold air sinks. Di dalam 2025, Inovasi termasuk:

Film yang dapat terbiodegradasi: Manufacturers are experimenting with polylactic acid (TPR) and cellulose films that can be FDA compliant. These reduce plastic waste but may have shorter shelf lives.

Sensor pintar: Realtime data loggers with Bluetooth or cellular connectivity alert shippers to temperature excursions. Lebih 70 % of shippers now require realtime monitoring for pharmaceuticals.

Sistem Hibrida: Menggabungkan es kering dengan reusable PCMs reduces the required amount of dry ice and limits supercooling. Farmasi & biotech companies are validating packaging against both undercooling and supercooling, incorporating monitoring and barrier technologies.

Distributed production: To avoid supply shortages, manufacturers are building local CO₂ production hubs and diversifying suppliers.

Key takeaways for travelers and small shippers

Match the format to your needs: Use thin dryice sheets or pellets for small, wellinsulated containers and blocks for longer journeys.

Invest in highperformance insulation: Vacuuminsulated panels and EPS with high density slow sublimation and extend hold time.

Balance dry ice with PCMs: Many pharma companies now use solusi hibrida that combine dry ice with PCM bricks to mitigate extreme cold.

Plan for volatility: Supply shortages and price swings may affect availability. Consider reusable PCM and gel packs as backups.

Pertanyaan yang sering diajukan (FAQ)

Q1: Can I bring a dry ice sheet on an airplane for my insulin?

Ya, but there are strict rules. Airlines and the FAA limit dry ice to 2.5 kg (5.5 lb) per passenger or package. The package must vent CO₂ gas and be marked “Dry ice” or “Carbon dioxide, padat” dengan berat bersih. Always check with your airline and ensure your container is vented and labeled. Consider using gel or PCM packs when possible to avoid extra paperwork.

Q2: What’s the ideal temperature range for insulin during travel?

Insulin should be kept di antara 36 °F dan 46 ° f (2 °C–8 °C) according to FDA guidelines. Unopened insulin stored in this range remains potent until its expiration date. Setelah dibuka, it can be kept at room temperature (59 °F–86 °F) hingga 28 hari -hari, but it should never freeze. If insulin is exposed to extreme temperatures or freezes, discard it and use a new vial or pen.

Q3: How much dry ice should I use for a 48hour insulin shipment?

Aturan umum adalah 5–10 lb es kering per 24 jam. For a 48hour shipment in hot conditions, you might need 0.5–0.8 kg of dry ice per day alongside multiple +5 °C batu bata PCM. Always ensure dry ice stays outside the PCM layer and that the container is vented.

Q4: What’s the difference between dry ice sheets, gel packs and PCM bricks?

Dry ice sheets contain solid CO₂ at –78 °C and offer intense cold for frozen goods but can freeze insulin. Paket gel membeku 0 °C and provide cooling for 12–36 hours; they’re reusable and don’t require hazardous labeling. PCM bricks designed for +5 °C maintain insulin safely within 2–8 °C for 24–48 hours and are the best choice for most insulin travel.

Q5: How do I check if a dry ice sheet is truly FDA compliant?

The FDA does not approve dry ice itself. Alih-alih, check that the bahan pengemasan (film, gel and sealants) are listed in the FDA’s food contact substance inventory. Ask your supplier for Food Contact Notification (FCN) dokumentasi and verify that the outer film is HDPE/PP and the gel is foodgrade polymer. Also confirm that the product comes with proper UN1845 labeling and hazard class 9 tanda.

Q6: Are there ecofriendly options for dry ice sheets?

Ya. Di dalam 2025, some manufacturers use biodegradable polymers like polylactic acid (TPR) or cellulose for outer films. These materials can be FDA compliant but may have shorter shelf lives. You can also reduce dryice use by opting for sistem hibrida that combine smaller amounts of dry ice with reusable PCM bricks, cutting CO₂ usage and waste.

Ringkasan & Rekomendasi

Kunci takeaways:

Dry ice itself is not FDA approved—only the packaging materials are regulated, and CO₂ always sits at –78 °C.

Insulin must stay between 2 °C dan 8 ° C.; direct contact with dry ice will freeze and denature it.

To use dry ice sheets safely, build a layered packout: precondition +5 °C batu bata PCM, wrap insulin in PCM, tambahkan isolasi, then place dry ice outside the PCM layer.

Label, vent and follow regulations: Mark packages “Dry Ice/Carbon Dioxide, Padat", include net weight, vent the container and respect the 2.5 kg airline limit.

Mempertimbangkan gel packs or PCM bricks as safer alternatives; they avoid hazardous labeling and maintain 2–8 °C without freezing.

Rekomendasi yang dapat ditindaklanjuti:

Pilih pendingin yang tepat: Untuk perjalanan di bawah 24 hours or moderate climates, menggunakan +5 °C PCM bricks or gel packs. Reserve dry ice for long journeys in high heat and always buffer it with PCM.

Check compliance: Verify that any dry ice sheet or pack uses FDA compliant films and gels. Ask for documentation and ensure UN1845 hazard labels.

Prepare properly: PCM pra-kondisi, layer them around insulin, ventilate the container and add a temperature logger. Perform a trial run to confirm the system before real travel.

Tetap mendapat informasi: Ikuti terus 2025 innovations such as biodegradable materials and smart sensors. These can reduce waste and give you realtime assurance during transit.

Hubungi ahli: For complex shipments or highvalue pharmaceuticals, consult a coldchain specialist like Tempk to design a validated packaging solution tailored to your route and ambient conditions.

Tentang TempPK

TemPK is an innovative coldchain technology company specializing in kemasan terisolasi, ice packs and phasechange materials for food and pharmaceuticals. Kami berkembang reusable dryice packs, +5 °C PCM bricks and vacuuminsulated boxes designed to maintain stringent temperature ranges. R&D center focuses on sustainable materials and smart temperature monitoring. We hold international quality certifications and operate ecofriendly production facilities. Dengan menggabungkan sciencebased design and fieldtested solutions, we help customers ship temperaturesensitive goods safely and sustainably.

Panggilan untuk bertindak: Need help designing a compliant packout for insulin or other medicines? Contact TemPK’s coldchain experts to get a customized solution. We can assess your route, calculate the right combination of PCM and dry ice, and provide validated packaging to ensure your medicines arrive safely.