仪器设备
神隆医药（常熟）有限公司的设备建设、试俥及验证共分为两期工程。第一期工程包括小型、中型API生产线S1/S2、M1以及配套的洁净区CR1/CR2, 大型中间体生产线L1与L2。在最低职业暴露限制值（OEL）1μg/m3下，S1与M1分别搭配CR1与CR2均可生产高活性化合物，S2可生产前列腺素产品。第二期工程共有两条大型生产线分别为：L3、L4、以及配套的洁净区CR3/CR。這兩條生產線採用高度自動化控制，可以很好保證生產設備的控制性能，同時不同材質的反應釜可以非常靈活因應各類反應的需要。结合常熟厂现有各类生产设施，既可依客户需求生产各种大量的原料药，亦有小规模设备可以配合制程发展的需要生产小量的新产品，以供制剂生产、研发、临床实验及销售评估使用。除了以上的生产能力外，常熟厂区还将提供所有必要的支持设施，包括实验室、仓库、维修设备、净水处理以及废弃物处理等。
生产能力
Scale | Name | Category | No. of Main reactors | Capacity (L) | Total reactor Volume (m3) |
Small | S1/CR1 | API | 6-G/L, 1-SS | 30 ~ 50 | 0.33 |
Small | S2 | Prostaglandin | 5 Glass | 1~50 | 0.11 |
Medium | M1+CR2 | API | 6-G/L, 2-SS | 300 ~ 1,000 | 5.1 |
Large | L1 | Intermediate | 5-G/L, 1-SS | 3,000 ~ 8,000 | 34.3 |
Large | L2 | Intermediate | 7-G/L, 3-SS | 1,000 ~ 8,000 | 52.2 |
Large | L3+CR3 | API | 4-G/L, 2-SS,1-HC22 | 3,000~12,000 | 50.0 |
Large | L4+CR4 | API | 5-G/L, 2-SS | 3,000~10,000 | 46.0 |
Sum of Total Reactor Volume: 188M3 | |||||
S1/CR1, S2, and M1/CR2 capable of producing highly potent APIs with OEL at 1 μg/M3
Small & Large FitzMill for milling & FPS ProMill for micronization
Two sets of PPW systems (200 and 2,000 L/hr )
Hydrogenation ( 200L and 1,200L )
G/L and HC22 temperature range : -19/180℃ (jacket)
SS316L temperature range : -100/180℃ (jacket)
SS304 temperature range : -40/180℃ (jacket)
高活性优势
5-band API health classification & industrial hygiene management program
SAR Software to predict the toxic hazard of chemicals
Permitted Daily Exposure (PDE) approach for toxicity assessment
Physically separate solid handling operations for material charging and independent air handling system for each production suite
Degree of protection varies by compounds
Totally enclosed isolators for charging, discharging, and milling
Continuous Liner for discharging and transferring
Differential pressure ventilation systems
Personal protective equipment
Containment verification of isolators by following ISPE guideline
Conduct initial and periodic monitoring to verify the effectiveness of containment control equipment or technologies
Medical evaluation and assessment of workers’ exposure
Training Programs for Potent Compound Safety Awareness