Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications
Product Description
Marya GMP-compliant formulation system ensures precise and consistent production of pediatric oral suspensions, meeting stringent FDA and EMA regulatory requirements. Designed for accuracy in low-dose formulations, this system integrates automated dosing, homogenization, and viscosity control to handle sensitive APIs and flavor-masking excipients. The closed-loop design prevents cross-contamination, while CIP/SIP functionality simplifies cleaning validation. Compatible with sucrose-free and dye-free formulations, it supports real-time PAT (Process Analytical Technology) monitoring for critical quality attributes. Ideal for antibiotics, antimalarials, and vitamin suspensions, our system reduces batch variability and accelerates scale-up.
Classification:
1)General formulation system: It is used for general small molecule chemical preparation, such as aqueous injection, lyophilized powder injection and so on.
2)Complex formulation system: It is used in the production of preparations with complex processes, such as suspensions, emulsions, liposomes, microspheres and other special preparations.
3)Biological formulation system: It is used for the preparation of various products of biological engineering technology, such as the semi-finished preparation of antibodies, vaccines, blood products, recombinant proteins and so on, and it can also be used for the preparation of culture medium production, purified buffer solution and other auxiliary liquid.
Design parameters:
| Volume |
2~15000L |
| Material |
304,316L,904L,TA2 |
| Stirring type |
Upper mechanical stirring, lower magnetic stirring |
| Stirring speed control accuracy |
Speed range 0~450rpm |
| Temperature control accuracy |
Temperature range-10~150ºC |
| Pressure control accuracy |
Pressure range-0.01Mpa~0.06Mpa
±0.01MPa |
| Weighing control accuracy |
3‰ |
| Power supply |
380V 50Hz |
Why Choose Our Formulation System?
- Quality and Compliance: Ensures that your products meet the highest quality standards and regulatory requirements.
- Flexibility and Customization: Adapts to various production needs and scales with ease.
- Efficiency and Cost-Effectiveness: Streamlines operations, reduces resource waste, and lowers overall production costs.
- Safety and Reliability: Minimizes human error and maximizes the safety of your production environment.
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