Marya GMP-Validated Formulation System
for Sterile Ophthalmic Suspension Production
Product Description
The Marya GMP-Validated Formulation System is a state-of-the-art solution designed for precision manufacturing of sterile ophthalmic suspensions. This system ensures ultra-homogeneous particle distribution (≤5μm) through high-shear rotor-stator mixing and ultrasonic deagglomeration, while maintaining ISO Class 5 environmental conditions. Equipped with automated viscosity control and in-line particle size monitoring, it guarantees batch-to-batch consistency for sensitive ophthalmic formulations. The pre-validated SIP/CIP cycles and 316L stainless steel construction comply with cGMP, FDA, and EU Annex 1 standards. With closed-system processing and zero human intervention, Marya's system delivers sterility assurance (SAL 10-6) for antibiotic, anti-inflammatory, and lubricant eye suspensions, reducing contamination risks by 99.9%.
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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