Pharmaceutical Folding Carton with Tamper-Evident Seal — ISO 15378 Compliant
Quick Specs
| Category | Folding cartons |
|---|---|
| Material | SBS C1S 300-400gsm / Tamper-Evident Tear Strip / Hot Melt Adhesive / Braille Embossing / CGMP Environment |
| MOQ | 1000-3000 units |
| Price | $0.05-0.80/pc |
| Certification | ISO 9001, FSC, ISO 15378, GMP |
| Sample | 3-5 days |
| Production | 7-15 days |
Get a Quote
Free quote in 24 hours. Factory visits welcome.
+86-18934352881
qo82@icloud.com
Product Overview
Pharmaceutical folding carton with tamper-evident seal, manufactured by Guangdong Bincai Color Printing Co., Ltd. — Diamond Member on Made-in-China.com, Audited Supplier with 22 years (founded 2003). Our dedicated pharma packaging line operates in a CGMP-compliant controlled environment with restricted access, HEPA filtration, and documented SOPs meeting ISO 15378:2017 requirements for primary packaging materials. KBA Rapida 105 4-color and Heidelberg Speedmaster XL 7+1 UV offset presses deliver pharmaceutical-grade print precision with full batch traceability. Daily output: 1.7 million folded cartons. ISO 9001:2015, FSC Chain-of-Custody, and ISO 15378 certified.
This folding carton features an integrated tamper-evident mechanism — either a perforated tear strip along the top panel or a glued-end seal that shows visible fiber tear upon first opening. The carton is printed on pharmaceutical-grade SBS (Solid Bleached Sulfate) C1S 300-400gsm board with low-odor, low-migration inks suitable for direct food/drug contact packaging. Braille embossing capability ensures EU Falsified Medicines Directive (2011/62/EU) compliance for European markets. Child-resistant (CR) folding carton designs available per ISO 8317 / 16 CFR 1700.
Applications
| Industry | Application | Key Benefit |
|---|---|---|
| Pharmaceutical | OTC drug cartons, prescription medicine boxes, clinical trial kits | ISO 15378 compliant; full batch traceability; Braille embossing for EU compliance |
| Nutraceutical | Vitamin/supplement cartons, herbal remedy boxes, probiotic packaging | Food-grade inks; tamper-evident seal builds consumer trust |
| Medical Device | Diagnostic kit boxes, surgical instrument packaging, test strip cartons | Precision die-cut inserts for device retention; sterilization-compatible board |
| Veterinary Pharma | Animal medicine cartons, vaccine kit boxes, pet supplement packaging | Same CGMP standards; variable data printing for batch/lot/serial |
| CBD & Cannabis | Child-resistant folding cartons for regulated markets | CR-certified designs (ISO 8317); opaque board prevents product visibility |
| Cosmeceutical | Clinical skincare, dermatologist-dispensed products | Pharma-grade aesthetic signals medical credibility; spot UV for premium feel |
Customization Options
| Option | Specification | Notes |
|---|---|---|
| Board Grade | SBS C1S 300-400gsm (standard), GC1 250-350gsm, GC2 coated duplex | SBS preferred for pharma — bright white, low odor, excellent print surface |
| Tamper Evidence | Perforated tear strip (standard), glued-end with fiber-tear indicator, holographic seal label | Tear strip most cost-effective for high volumes; fiber-tear for visible first-opening proof |
| Printing | CMYK offset + Pantone spot + low-migration UV curing | Low-migration inks per EuPIA guidelines; no mineral oil migration risk |
| Braille | Raised Braille embossing on front panel | EU Directive 2001/83/EC compliant; tooling cost ~300 USD per design |
| Child-Resistant | Reverse-tuck with locking tab, push-and-turn mechanism insert, CR-certified design | ISO 8317 / 16 CFR 1700 testing available through partner lab |
| Variable Data | Inkjet batch/lot/expiry/serial, 2D DataMatrix, GS1 barcode | Thermal inkjet inline with die-cutter; GS1-128 and Pharmacode supported |
| Surface Finish | Aqueous coating (standard), UV varnish, matte/gloss lamination | Aqueous preferred for pharma — no UV photoinitiator migration risk |
| MOQ | 1,000-3,000 units | Tooling: die-cutting forme ~150 USD, Braille set ~300 USD |
| Sampling | Digital proof (2 days), flat blank (3-5 days), finished carton (7 days) | CGMP documentation package included |
| Lead Time | 10-15 working days | 20 days for first-order with new tooling |
Production Specifications
| Specification | Detail |
|---|---|
| Board | SBS C1S (Solid Bleached Sulfate) 300-400gsm, brightness ≥92% ISO, smoothness ≤1.5µm PPS |
| Production Environment | CGMP-compliant, restricted access, HEPA filtered, temperature 20-25°C, RH 45-55% |
| Inks | Low-migration UV-cured offset inks, EuPIA GMP compliant, <10 ppb TOC migration |
| Presses | KBA Rapida 105 4-color (15,000 sph) + Heidelberg Speedmaster XL 7+1 UV |
| Die-Cutting | Bobst Autoplaten SP 102, ±0.2mm tolerance, 8,500 sph |
| Gluing | Bobst Expertfold 110 A2, hot-melt adhesive, 100% glue-line inspection sensor |
| Variable Data | Domino thermal inkjet, 600 dpi, inline with folder-gluer |
| Batch Traceability | Full traceability from board reel to finished carton lot; retained samples 3 years |
| Daily Output | 1.7 million folded cartons |
| Factory Size | 18,000 sqm Foshan (10,000 original + 8,000 Gaobu smart factory, 2025) |
| Certifications | ISO 9001:2015, ISO 15378:2017, FSC Chain-of-Custody, GMP, BSCI |
Quality Assurance
| Checkpoint | Standard | Method |
|---|---|---|
| Board Caliper | ±5% of nominal (e.g., 350gsm ±17.5µm) | Digital micrometer, 1:500 |
| Print Registration | ≤0.15mm CMYK-to-CMYK | Magnification loupe with reticle, 1:500 |
| Color Consistency | ΔE ≤2.0 within batch, ΔE ≤3.0 batch-to-batch | X-Rite spectrophotometer, every 1,000 sheets |
| Braille Dot Height | 0.3-0.5mm above surface | Digital height gauge, 1:200 |
| Tamper Evidence Function | Tear strip breaks cleanly with ≤15N pull force | Tensile tester, 10 pcs/lot |
| Glue Bond | Fiber tear ≥60% of glued area | Manual peel test, AQL 1.0 |
| Carton Squareness | ≤1.0mm deviation when folded | Go/no-go jig, AQL 1.5 |
| Ink Migration | <10 ppb TOC (EU), <50 ppb (other) | GC-MS migration testing per EuPIA, annual + per batch |
| Bar Code Grade | ANSI Grade B (3.0) or better | Bar code verifier, 1:500 |
| Particle Count | ≤10 particles >50µm per carton interior | Optical particle counter, 3 pcs/lot |
Why Choose Bincai for Pharmaceutical Cartons
-
ISO 15378 Certified: This is the specific ISO standard for primary packaging materials for medicinal products. Bincai is one of the few Chinese packaging manufacturers holding this certification, demonstrating our documented CGMP compliance, contamination control, and batch traceability systems.
-
Dedicated Pharma Line: Our pharmaceutical carton production runs on a segregated line within the 18,000 sqm facility — HEPA-filtered air, restricted personnel access, documented cleaning protocols, and separate tooling dedicated to pharma to eliminate cross-contamination risk.
-
Regulatory Documentation: We provide a full Drug Master File (DMF)-equivalent documentation package with every order: board certificates of analysis, ink migration test reports, CGMP batch records, retained sample log, and certificate of compliance to ISO 15378.
FAQ
Q: What’s the difference between ISO 9001 and ISO 15378? A: ISO 9001 covers general quality management. ISO 15378:2017 is specifically for primary packaging materials for medicinal products — it adds CGMP requirements including contamination control, validated cleaning, personnel hygiene, controlled environment, risk management (ICH Q9), and full batch traceability. It’s the packaging equivalent of pharma GMP manufacturing.
Q: Can you print variable data (batch, expiry, serial number) on each carton? A: Yes — our Domino thermal inkjet system prints variable data inline at 600 dpi during folder-gluer operation. We support lot numbers, expiry dates, serial numbers, 2D DataMatrix codes, GS1-128 barcodes, and Pharmacode. Variable data is verified by camera inspection with reject diversion.
Q: Do you offer child-resistant (CR) folding cartons? A: Yes — we manufacture CR-certified designs including reverse-tuck with locking tab (CR-lok style) and push-and-turn insert cartons. Testing to ISO 8317 / 16 CFR 1700 is arranged through an independent certified lab. CR design adds approximately 15-25% to per-unit cost and requires 3,000+ MOQ.
Q: What’s your minimum order for Braille embossing? A: Braille embossing requires a dedicated embossing die (~300 USD one-time) and adds a post-print embossing step. MOQ is 2,000 units to amortize setup. Braille text must be provided by the customer per regulatory requirements; we can advise on correct Braille grade specification.
Guangdong Bincai Color Printing Co., Ltd. — 22 years of packaging excellence. ISO 9001:2015, ISO 15378:2017 & FSC certified. 18,000 sqm Foshan facility. KBA Rapida 105 + Heidelberg Speedmaster XL 7+1 UV + Bobst Autoplaten SP 102 + Bobst Expertfold 110. Daily output: 1.7M cartons. Serving 60+ countries worldwide. Diamond Member on Made-in-China.com.
Why Choose Bincai
22 years · ISO 9001 · FSC Certified · 1.7M boxes/day · 200+ global brands
| 🏭 Experience | 22 years since 2003 |
| 📐 Factory | 18,000m² (10,000+8,000 smart factory) with KBA & Heidelberg presses |
| ✅ Quality | ISO 9001:2015 certified |
| 🌿 Eco | FSC certified sustainable materials |
| 🚀 Capacity | 1.7M+ color boxes + 220K+ gift boxes daily |
| 🎨 Custom | Any size, color, finish, insert |
| 📦 MOQ | 500-1000 pcs, trial orders accepted |
| 🆓 Sample | Free pre-production sample (freight collect) |
| 🌍 Shipping | Worldwide DHL/FedEx/UPS/Sea |
Related Products
