Sterile Plant Manufacturer
Propack Technologies’ sterile injectable processing systems for batch sizes ranging from 5 L to 30,000 L are suitable to manufacture sterile solutions like vials, IV fluids, Aerosols, Ampoules, LVP - SVP solutions and other similar products. We offer completely customized systems adhering to cGAMP and ASME BPE guidelines for aseptic manufacturing.
We offer a full range of process vessels and their automation - comprising optional SCADA package - as well as all associated peripherals including suction pumps, CIP/SIP systems, and the filling line interface with transfer pump.
Benefits
- 1 Aseptic mixing & blending vessels designed as per ASME BPE / cGAMP / PED / USFDA
- 2 Bottom mounted magnetic mixer as per requirements
- 3 Skid customized & engineered as per process requirement
- 4 Complete CIP / SIP able system with 100% drain
- 5 In-house programming expertise to design customized recipe cycles
- 6 Automation as per 21 CFR part 11
We offer the following customizations according to client specific needs:
- Manufacturing vessel
- Holding Vessel
- Magnetic Mixers
- Sampling Valve
- Conductivity Sensor
- DO sensor
- pH Sensor
- Product Filter
- CIP - SIP of entire skid
A standard sterile aseptic manufacturing system comprises of two vessels although the systems might vary considerably according to each individual needs. Complete isolation from contamination is the main consideration in sterile manufacturing. Each vessel is therefore designed as per cGAMP and ASME BPE guidelines. The vessels can be customized as per the client needs to include magnetic mixers as per product needs. Various sensors like pH sensor, DO sensor, Conductivity sensor, Level sensor and charting devices can also be included into the system as per needs.
The operations of centrifugal pump, pneumatically operated valves (in case of automated operation) and mixers is carried out through the main control panel. The panel is made out of SS304 grade material and consists of various safety lock systems like the Emergency stop and Mains supply indicators for safe work and extended component life. The vessels are connected to each other via interconnecting pipelines manufactured as per cGMP norms and connected with sealed tri clamp connection.
Features of our system:
- Uniform ingredient dispersion
- No wall caking
- Entire plant operation by one operator and one helper
- Efficient heat transfer in the vessels
- Particle size reduction less than 5 microns
- Reduced batch processing time
- Reduced change over time
- Consistent product composition across different batches
- All contact parts made of SS316L and non-contact parts made of SS304 grade material
- Food grade silicone gaskets
- Vessel design as per ASME guidelines
- Torispherical, Hemispherical and Conical dish top customization availability
- Hydraulic lid lifting arrangement for occasional cleaning
- Static & Dynamic spray ball availability
- VFD for motor rpm controls
