OUR VISION
At SterVAC, our vision extends beyond just providing products. We aspire to be strategic partners, aiding our clients in achieving operational excellence, enhancing safety protocols, and fostering a productive environment
PHARMACEUTICAL ISOLATORS OR BARRIER CONTAINMENT SYSTEM
Pharmaceutical isolators are highly specialized containment systems used in the pharmaceutical industry to handle substances that require a controlled environment to ensure safety, sterility, and product integrity. These isolators provide a barrier between the operator and the product, maintaining a controlled environment by controlling factors like air quality, pressure, temperature, and humidity.
They are designed to prevent contamination of the product being handled and to protect operators from exposure to hazardous materials. Isolators typically consist of sealed chambers made of materials that are resistant to corrosion such as stainless steel. These chambers often have gloves attached, allowing operators to handle substances inside without direct contact.
Isolators can be used in various pharmaceutical processes, including compounding sterile drugs, handling toxic substances, manufacturing pharmaceuticals, and conducting research involving potent or hazardous compounds. Some isolators are equipped with advanced features such as HEPA (High-Efficiency Particulate Air) filters and airtight seals to maintain sterility and prevent the release of contaminants into the environment.
Their design can vary based on the specific requirements of the substances being handled and the processes involved. They play a crucial role in ensuring product quality, protecting personnel, and complying with regulatory standards in the pharmaceutical manufacturing industry.
Negative (Pressure)
OSD
Formulation
Injectable
Positive (Pressure)
Biologicals
Sterility/ Microbiology Testing
H2O2 Decontamination / Sterilization
TYPES OF ISOLATION / CONTAINMENT
AT SterVAC WE PROVIDE
- Fixed / Mobile (In Built Power Panel)
- ATEX Rated FLP / NFLP
- OEL 4-5
- OEL Validation / Studies with reputed CIH
- Ergonomically Designed for ease of access
- Glazing / Toughened panel for clear visibility of Operating surface
- Command station (Push button - FLP / NFLP)
- Hermetically Designed Programming Logic Control in HMI
- Integrated with Process Equipments (ANFD, Reactors, RMG, Blender, Mill etc)
- Barrier of access control for rotating equipment - add on safety
- 21 CFR, Part 11 Compliance
- CE Certification
AT SterVAC WE OFFER DOCUMENTATION
- Quality Assurance Plan
- Design Qualification
- Factory Acceptance test
- AS Built Drawings (GA, P & ID, Electrical)
- Installation Qualification
- Operation Qualification
- OEL Studies/Validation
- BI/CI Testing/ Validation
- Functional Design Specifications
- HazOP Studies