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{"title":"Integrated Aseptic Ampoule Processing and Sealing Line (1-20ml) Zero-Contaminati","imgUrl":"https:\/\/img.chinax.com\/nimg\/b6\/0b\/cfa9b3cf77b13248065b2d5bca60-200x200-1\/integrated_aseptic_ampoule_processing_and_sealing_line_281_20ml_29_0azero_contamination_automation_with_oxyhydrogen_hermetic_seali.jpg","attrs":{"Brand Name":"Lingyao","Model Number":"LYAPL1-20-I","Certification":"CE, ISO, GMP","Place of Origin":"China"}}
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{"title":"Integrated Aseptic Glass Ampoule Filling and Sealing Line (1-20ml) Climate","imgUrl":"https:\/\/img.chinax.com\/nimg\/b5\/74\/cb149c0a306e671ea9c5d5b3b543-200x200-1\/integrated_aseptic_glass_ampoule_filling_and_sealing_line_281_20ml_29_0aclimate_resilient_automation_engineered_for_sfda_and_halal.jpg","attrs":{"Payment Terms":"D\/A,D\/P,T\/T,Western Union","After-sales Service & Technical Support":"1-2 years guarantee maintenance, free spare parts available, and trouble assistance to minimize downtime","Nitrogen Filling":"Available","Filling Liquid Type":"Injectable Vaccines"}}
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-ing Traceability
Integrated QR code tracking from raw material to batch release, compliant with FDA DSCSA requirements for controlled substance tracking.
Technical Parameters Table
Parameter
LYAPL1-20 Specs
Industry Standard
Capacity
8,000-3,0000 ampoules/hour
3,000-6,000 ampoules/hour
Dosing Accuracy
±0.5% (1-20ml range)
±1.5%
Sterilization Temperature
350°C (max)
250-280°C
Airflow Cleanliness
Class 100 (ISO 5)
Class 10,000 (ISO 8)
Changeover Time
≤15min (modular tooling)
45-60min
Target Applications
Non-Opioid Management: High-precision filling of capsaicin-based neuropathic 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 manufacturing compliance.
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer
Year Established:
2013
Total Annual:
5,000,000-10,000,000
Employee Number:
50~200
Ecer Certification:
Verified Supplier
Since opening our doors in 2013, Suzhou Lingyao Intelligent Equipment Co., Ltd. has built a solid reputation for providing innovative and reliable solutions to businesses across multiple industries. We offer a comprehensive range of products, from intelligent liquid filling lines to advanced labelin... Since opening our doors in 2013, Suzhou Lingyao Intelligent Equipment Co., Ltd. has built a solid reputation for providing innovative and reliable solutions to businesses across multiple industries. We offer a comprehensive range of products, from intelligent liquid filling lines to advanced labelin...