Yaohaibio Sterile Preparations
Service Ability
In March 2022 the new production line of Yaohaibio macromolecular drug R&D and production service was put into operation, including a new sterile production line for PFS syringe/cartridge. There are two additional filling forms of pre-filled syringes and cartriges to the original injection and lyophilized vials, which further enriched Yaohaibio’s product variety and enhanced its abilities to satisfy customer’s production requirements for different production lines.
In terms of sterile preparation production, Yaohaibio has built a production workshop for various types of preparations with a purification area of 2000 square meters. There are all automatic control production lines integrating vial washing, sterilization, filling, lyophilization, capping and other processes, of which the design, construction and control standards meet the requirements of GMP in China, the European Union and the United States. With rich production experience in the production of biopharmaceutical sterile preparations, we provide high-quality production services from small-scale clinical sample production to large-scale commercial production for vial and PFS production.
Sterile preparation services
IND, clinical phase I/II/III and commercial manufacturing
Comprehensive layout of vial water injection, lyophilized powder, PFS sytringe/cartrige preparation production lines
Types of fillable products: mainstream biological products such as recombinant proteins, peptides, plasmids, antibodies, vaccines, etc.
Sterile Preparation Production Lines of Injections and Lyophilized Vials
1. Filling specification range
o1ml-25ml
2. Sterile production line
oO-rabs system is adopted to carry out Grade B environmental protection for the exposure areas of the product (and packaging materials)
oFully automatic feeding and discharging system
oFully automatic SIP/CIP system of lyophilizer
oOnline nitrogen charging system is equipped for nitrogen charging protection
oPMS online monitoring system
3. Filling accuracy
oHigh filling accuracy: (WFI as filling medium) ± 0.25%
4. Filling speed
oCalculated based on 2ml vials, the maximum production speed is 300 vials/min, and the maximum lyophilization batch size is 37800 vials/batch
Sterile Preparation Production Lines of PFS syringes and cartridges
1. Filling process
oSupport the plunger pump, peristaltic pump and vacuum filling forms, to meet the filling process requirements of different drug liquids
2. Filling specifications
o1ml and 3ml pre-filled syringes, 3ml cartridges
3. Sterile filling
oNitrogen filling system is equipped to meet the antioxidant process requirements in the filling and storage of drug liquid
oVacuum stoppering, which is a non-destructive stoppering method and applicable to many types of rubber stoppers
oThe exposed areas of the product and packaging materials are protected in a Grade A clean environment
oPMS online monitoring system is adopted to realize real-time monitoring of the sterile production environment and data traceability
At present, Yaohaibio can provide the filling service with a maximum annual output of 8 million vials of PFS syringes/cartiges, 10 million vials of injections, and 5 million vials of lyophilized powder.