De Nester Plunger Road Insertion & Sticker Labeling Machine
De Nester Plunger Road Insertion & Sticker Labeling Machine
Manually loading Syringes nest into the de-nesting stand. Automatic de-nesting of PFS from de-nesting stand. Automatic insertion and threading of plunger rod into PFS. High and robust labeling accuracy. Easy access to the individual station because of the Narrow machine’s compact design.
Technical Specification :
Nest System | Inspection System | System | Speed | |
RI/PFS/LAB/01 | AUTO denesting/Manual Denesting | Vision Syatem | IPC Scada | 60-120 Per min |
RI/PFS/LAB/01 | AUTO denesting/Manual Denesting | None | HMI | 60-120 Per min |
Optional Accessories :
- Automatic loading/unloading of the nest
- Checkweighing of the dose
- Gas Flushing before, during or after the filling process
- SCADA software to process data acquisition in accordance with 21 CFR
- Particle monitoring and counting
- Laminar Flow / RABS / Isolator
- IQ / OQ validation package
Documentation & Qualification
- In pharmaceutical production, Good Manufacturing Practices (GMP) are essential to guarantee that the manufacturing process is constantly controlled according to quality standards, and the drugs can be used safely.
- Therefore, there must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process, ensuring clarity and traceability of the product quality data acquisition.
- At RADIANT INDUSTRIES, we defined specific actions to ensure that our document management, which we call GDP (Good Documentation Practices), fulfills this objective.
- Document management starts with the client’s specifications (URS) which help us understand the customer’s needs and define the machine’s configuration accordingly. The required machines’ functionality will be tested later during the qualification tests.
- The whole process is described in the picture below, showing the comprehensive Qualification Project Plan (QPP) that covers from mechanical assembly to software and control configuration: