Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy

Precision Engineered for High-Risk Analgesic Formulations

⚙️ Key Differentiators vs Competitors
✅ Endotoxin-Free Sterility

• Combines ultrasonic cleaning (99% particulate removal) and dry heat sterilization (300°C/5min) to achieve SAL ≤10⁻⁶, critical for opioid-free analgesics.
• Nitrogen-protected filling chamber prevents oxidation of NSAIDs (e.g., ketorolac tromethamine).

✅ Micro-Dose Precision

• Peristaltic pump system with ±0.5% volumetric accuracy, ensuring consistency in low-volume formulations (1-20ml ampoules) for epidural/parenteral analgesia .

✅ Anti-Counterfeiting Traceability

• Integrated QR code tracking from raw material to batch release, compliant with FDA DSCSA requirements for controlled substance tracking.

Technical Parameters Table

Target Applications

• Non-Opioid Pain Management: High-precision filling of capsaicin-based neuropathic pain solutions.
• Postoperative Analgesics: Aseptic production of ropivacaine/bupivacaine ampoules for nerve blocks.
• Migraine Therapies: Oxygen-sensitive triptan formulations (e.g., sumatriptan) with nitrogen shielding.

Certifications

• GMP, ISO 13485, and FDA 21 CFR Part 11 compliance .
• Validated per EMA Annex 1 guidelines for sterile medicinal products.

Why Suzhou Lingyao?

• 8+ years specializing in controlled substance production equipment .
• Customizable CIP/SIP systems for Schedule II-V drug manufacturing compliance.

Established in 2013, Suzhou Lingyao Intelligent Equipment Co., Ltd. has a strong reputation for providing innovative and reliable solutions to meet the diverse needs of companies. The company's product range includes a wide variety of equipment such as intelligent filling machines, labeling & packaging machines, also include medical blister packagings and injection madical devices.

With a team of experienced engineers and technicians, Suzhou Lingyao Intelligent Equipment Co., Ltd. provides customized solutions to meet the specific requirements of its customers. The company also offers excellent after-sales service and technical support to ensure customer satisfaction.

Overall, Suzhou Lingyao Intelligent Equipment Co., Ltd. is known for its commitment to quality, innovation, and customer service in the intelligent equipment industry.