Iranian customers visit the production site of anesthesia masks

Case Study: Iranian customer purchased the production line for Slush Molding anesthesia masks: seamless, soft material, medical-safe, fully compliant, stable production capacity, and excellent after-sales service.

 

 

- Client: A subsidiary of a prominent local medical consumables group in Tehran, Iran.
- Product: Disposable slush-molded anesthesia masks (full range of sizes: adult, pediatric, and infant)
- Requirements: Local Iranian production to replace imports, cost reduction, and stable supply; target annual output of 2 million units.
- Timeline: Initial contact in October 2024 → Contract signed in March 2025 → Equipment shipped in June 2025 → Mass production in August 2025.
- Key challenges: Iran IFDA registration, ISIRI certification, payment and logistics amidst sanctions, and technology localization.

 

1. Manufacturing Process: Slush molding is mandatory. Iranian hospitals specify soft, seamless cuffs that offer high sealing performance and are hypoallergenic; blow-molded products (which are rigid, have seams, and are prone to air leakage) are rejected.
2. Material Requirements: Medical-grade PVC paste resin; compliant phthalate (DEHP) levels; ISO 10993 biocompatibility certification.
3. Production Capacity: 800–1,000 units/hour per line; annual output of 2 million units.
4. Compliance: Full documentation package including ISO 13485, CE, IFDA, and ISIRI certifications; bilingual (Persian and English) documentation.
5. After-Sales Service: Local installation, training, and spare parts inventory in Iran; 1-year warranty plus lifetime technical support.

 

 

The client's CEO, Technical Director, and Head of QA visited China for an on-site factory audit:1. Inspection of slush-molded mask samples: Conducted squeezing, stretching, folding, and inflation tests; verified seamless construction, superior softness, excellent resilience, and a leak-proof seal.
2. Inspection of existing production lines: Fully automated slush molding machines, temperature control systems, molds, post-processing, and packaging.
3. Document review: ISO 13485 certification, Material COA, biocompatibility reports, CE marking, and export records.

4. Technical Verification:
- Mold: 4 cavities per mold; three sets of molds (adult, child, and infant sizes)
- Temperature Control: Precise control within the 180–220°C range (±1°C)
- Materials: Materials of equivalent specifications are available locally in Iran; we provide the formulation.5. Customer Conclusion: Quality is superior to that of the Turkish supplier; the price is reasonable; suitable for cooperation.

 

 

Fully Automatic Rotational Molding Production Line for Anesthesia Masks (1 Line)

- Main Rotational Molding Unit: 4-station rotary type; features automatic loading, preheating, dipping, curing, cooling, and demolding.
- Molds: 1 set each for Adult (Size 5), Child (Size 3), and Infant (Size 1); 4 cavities per set.
- Temperature Control System: Intelligent PLC; adjustable temperature, timing, and rotation speed.
- Post-processing: Trimming, hole punching, and air cushion inflation testing (pressure retention for 5 minutes without leakage)
- Packaging: Automatic bagging, sealing, and labeling (Persian language labels)
- Production Capacity: 800–1,000 units/hour.
- Footprint: 12m × 6m; Power Supply: 380V/50Hz.

 

 

 
1. Price: FOB Guangzhou, China (includes training, installation, and 1 year of spare parts)
2. Payment: Via T/T and third-party cross-border payment (due to sanctions)
3. Documentation:
- Full set of ISO 13485, CE, IFDA, and ISIRI certifications (embassy-certified)
- Persian and English versions of: operation manuals, maintenance manuals, formulation manuals, and quality control documents.
- Material MSDS, COA, and biocompatibility reports.
4. Delivery Lead Time: 4 months (including production, commissioning, and training)

 

 
- March 2025: Formal contract signing; payment of 30% down payment.
- March–May 2025: Equipment manufacturing, trial runs, mold development, and sample approval.
- June 2025: Equipment completion; customer visits China for Factory Acceptance Testing (FAT); shipment arranged upon approval.

 

We will dispatch two senior engineers to Tehran to carry out the following:
1. Equipment installation, wiring, and commissioning (to be completed within 7 days)
2. Personnel training (operation, maintenance, and QC):
- Optimization of slush molding parameters (temperature, time, and rotation speed)
- Mold disassembly, assembly, cleaning, and maintenance.
- Quality control: appearance, wall thickness, inflation testing, and Shore hardness (Shore A 60±5)
- Troubleshooting common faults.
3. Trial production: 72 hours of continuous operation with a pass rate of ≥99.5%.

 

 
- End of August 2025: Official mass production commenced, with a daily output of 6,000–8,000 units supplied to hospitals across Iran.
- Quality Feedback: Seamless, soft, excellent sealing, and low allergy rates; highly rated by hospitals.
- Follow-up: The client has commissioned a second production line and is negotiating projects for silicone urinary catheters, laryngeal masks, and other products.