Injectable - Isovax Technologies
ISOVAX specializes in the containment of airborne particles often present when handling drug compounds in Pharma, Biotech and allied applications, and has a team that has years of experience in the supply of proven containment solutions
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Isolators for Injectable Line

ISOVAX provides isolators for the product formulation and aseptic filling conditions, to reduce the contamination risk and ensure environmental control.

Isolators reduce the cost of maintaining the area under aseptic conditions as the class maintained in the area is limited to the Isolator; the surrounding area can be of the lower class.

The establishment of a validation discussion group aided the fundamental risk assessment by emphasizing the importance of human contamination in safe, effective aseptic processing. When evaluating the findings of the process simulations, it was clear that personnel was the sole significant source of microbiological contamination in aseptic processing/filling.
Combining an isolator with highly automated aseptic processing lines and/or filling lines has the potential to allow for operation in a microbe-free environment.

Isovax provides Isolators suitable for the following processes

Aseptic Processing, Aseptic Filling, Sterility Testing, Aseptic Testing & Sampling, and Aseptic Transfer.

All the isolators can be provided with Half suites/Full suites/air fed helmets, dust masks.

Aseptic Processing
  • Enclosure with GMP Class A ISO 5
  • Integrated Gasified Hydrogen Peroxide Bio-decontamination Systems recirculation unidirectional flow airflow system
  • Process dependability is controlled, resulting in a high-quality product with maximum efficiency.
  • Increased operator safety as a result of reduced contamination hazards.
  • Integration with the process equipment/ mixing vessels.
Aseptic Filling
  • Grade A conditions are provided by HEPA filtered unidirectional airflow, which prevents particle swirl.
  • Transfer systems move products and materials into and out of an isolator.
  • The isolator is decontaminated before the filling procedure begins.
  • All functions related to safety and GMP are continuously monitored and archived electronically.
  • Process in accordance with FDA and cGMP guidelines.
  • A decontamination process that is stable, effective, and repeatable.
  • Analysis of low-level H2O2 concentrations is carried out.
Sterility Testing Isolator
  • Pharmacopoeias require sterility testing of sterile pharmaceutical goods to evaluate the acceptability of a production batch. It’s an important part of sterilization validation, and it has to be done correctly to avoid both false-positive and false-negative outcomes.

 

  • False-positive results are usually caused by laboratory contamination from the testing environment or by technician/technique error, and they add to the workload by necessitating more paperwork. They also add to the cost by delaying or preventing the product’s release for sale.

 

  • The enclosure is designed to prevent erroneous results and to safeguard the product from both, the process and the externally induced influences that could damage its quality.

 

  • Systems can be decontaminated overnight automatically.
Aseptic Transfer Isolators
  • In containment technology, the transfer of items and instruments into and out of containment is an important process step and a key procedure.
  • There are several methods for transferring systems into containment isolators for various applications such as product protection, operator protection, and environmental protection, or a combination of the two.
  • The transfer out of the enclosure is just as crucial as the transfer in.
  • The transfer can be done in batches or in real time.