HIGH CONTAINMENT OPERATIONS
Capabilities in all Phases: Pre-Clinical, Clinical and Commercial
As a cost and time efficient solution provider, we service clients who are developing receptor-specific and hence – potent compounds that require HCO conditions. Our HCO facility handles the challenges of solid dosage forms they pose.
Our expertise and industry experience in containment infrastructure, maintenance, quality management system, testing, processing and other technical knowledge enables us to evaluate clients’ objectives more accurately, design a more suitable development strategy, offering them more confidence and more value added services in the course of their project development.
The capital investment in our HCO infrastructure — the technology, engineering, construction, and expertise — provides, and it shows, additional assurance that our clients’ HCO needs are fulfilled in regulatory compliance.
We have adapted technology advancements that reduce the level of manual or automated sampling for in-process control and monitor critical steps of the manufacturing processes, assuring the reliability of these processes. Our newly added technologies include:
• Isolator technology
• Automated self-adjusting equipment
• Process analytical technology (PAT)
• Specially designed WIP technology to remove most of the contaminants in the first step such as pre-cleanable tablet presses and coaters
• Separate areas for production, material and personnel air locks controlled by HVAC systems that use pressure cascade to contain any contaminants within the critica area and to provide increasing negative pressure towards the critical area
• Single-pass-through air-handling systems with high- efficiency particulate air (HEPA) filters in inlets and outlets, and with secondary filters in outlets to prevent contamination of the HVAC system and ductwork
• Suitably engineered docking systems in the production process, to ensure proper transfer of active ingredient blends from one closed system to the next in the production line
• Closed manufacturing systems
• Top-quality materials and construction of walls, ceilings and floors to resist repeated wash-downs and aggressive cleaning
• Separate analytical testing labs furnished with containment hoods or isolators for testing samples |
High Containment Facility Gallery and Large Stability Chamber |
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Why Stason?
- Technology: We have the in-house process expertise that high containment solid forms require.
- Capacity: We have the right capacity to accommodate the volume flexibly enough making us a viable option, from bench top to commercial manufacturing.
- Economic: Our HCO operations are efficient that cost savings are passed to our clients in the short term and long term.
- Quality: We follow stringent cGMP and can be expected to perform to industry quality standards and beyond. Detailed SOP’s, specific sampling procedures, cleaning procedures and analytical methods can be developed for each individual active compound. Upon request, dedicated equipment can be offered as an option.
- Reliability: If clients are virtual: We have a completely functional HCO facility to serve as their reliable manufacturing site and regulatory support, while our clients’ capital funds can be invested in clinical studies, sales and marketing, rather than manufacturing.
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