Aprazer Healthcare’s Quality Assurance as an Injectable Manufacturer

Manufacturing injectables requires a critical process of manufacturing and quality control compared to orals.

The parenteral being injected into the bloodstream needs to be sterile and safe.

Since water is used as a primary solvent, the quality parameters are stringent on the sterility of water.

The sterile manufacturing requires a proper air quality system to prevent cross-contamination.

This emphasizes the necessity of –

Advanced filtration, cleaned rooms, sterilization, and aseptic techniques for the process.

Aprazer Healthcare – Manufacturing the global quality injectables

As a pharmaceutical manufacturer, we are equipped with the latest advanced techniques to ensure sterility and safety of injectable preparations.

We strictly adhere to WHO-GMP standards.

From the manufacturing to the final filling, each step of the process is tested and controlled.

Our quality assurance parameters include –

• Raw material analysis
• In–process monitoring
• Finish product analysis
• Gowning & Personnel Validation

The critical quality attributes for injections- 

• Sterility – free of microorganisms
• Bacterial endotoxins- free of pyrogens
• Free of particulate matter
• PH and Osmolality – Isotonic with the body fluids
• Volume uniformity- the content should be equally dispersed for the intended dosage.
• API potency – Validation of API concentration and potency.

It requires manufacturing attributes as –

• Environmental control, clean rooms –

The manufacturing process must be carried out in clean rooms.

It must prevent contamination.

• Aseptic manufacturing – sterile conditions must be maintained.
• Depyrogenation technique – Adequate glassware or filtration to remove endotoxins.
• Terminal Sterilization – Autoclave /heat treatments
• Continuous monitoring – monitoring the pressure, temperature, errors, and flow of the material.

Finish product testing – 

• Sterility testing
• Endotoxin testing
• Particulate matter analysis
• Container Closure Integrity Testing (CCIT)
• 100% Visual Inspection

How does Aprazer Healthcare ensure adherence to operational criteria?

We are equipped with –

Advanced air filtration 

Grade A (class 100) conditions to control airborne contamination.

• HEPA filters – High-efficiency filters to eliminate particulate matter from the air.
• Laminar air flow system
• Positive pressure differentials to prevent contamination

Purified water systems 

• Double reverse osmosis
• Electrodeionisation
• Continuous loop system and UV treatment

We have an advanced manufacturing unit based on modern features – 

• Walkable false ceilings

• GI –powder-coated panels to prevent dust pockets in the corners.
• Interlocked doors
• Advanced HVAC systems
• Sanitization and disinfection
• Aseptic Process Simulation
• Gowning protocols

Partner with the top –quality injectable manufacturer – 

Aprazer Healthcare is a leading pharmaceutical manufacturer.

We specialize in manufacturing injectables.

We are the leading oncology injectable manufacturer and exporter.

Our portfolio for injectables –

• Critical care injections
• Oncology injections.