Environmental precautions for filling high viscosity drugs with pre filled syringe filling machine

1. Control the temperature and fluidity of the medicine solution

·Maintain stable temperature of the medication to preventmedicinal liquidviscosityAfter temperatureAffects filling.

·Use large-diameter or conical needles to reduce blockage and dripping.

2. Prevent bubbles and inaccurate dosage

·Before filling, degas the medicinal solution to reduce air bubbles.

·Using low-speed filling to avoid splashing or generating bubbles of the medicine solution.

·Use high-precision pumps (such as plunger pumps) to ensure accurate filling volume.

3. Strengthen clean environment management

·Filling area maintenanceCleanliness (ISO level 5), reducing the risk of pollution.

·Use isolators or、Laminar flow hood reduces pollution caused by personnel intervention.

·Increase the frequency of environmental monitoring, with a focus on particles and microorganisms.

4. Optimize the filling process

·Adjust the filling speed to avoid splashing or residue of the medication.

·Adopting an online weighing system to ensure accurate filling of each syringe.

5. Cleaning and residue control

·Choose easily soluble cleaning agents to clean the filling system.

·Check the tubing and needles to prevent residual medication from affecting the next batch.

·After cleaning, dry thoroughly to avoid microbial growth.

6. Personnel operation standards

·Reduce personnel entry into the filling area and lower the risk of contamination.

·Operators need to wear sterile clothing to avoid direct contact with medication and filling components.

·Record all operations to ensure traceability.