Purpose of Isolators – Promising Prudence, Purity and Perfection
With a team of dedicated engineers, our overriding objective drives our existence to make healthcare medicines accessible and affordable around the world. However medicines go through an extensive, diligent and prudent manufacturing process with absolutely no scope for slip-ups. This essential course of pharmaceutical development involves equipment to support purity throughout the entire production chain. One of the integral parts of equipment in the pharma industry are Isolators that provide a controlled environment, forming the crux of the pharmaceutical industry.
With shoulder-high gloves hanging on the glass, the very first look of these isolators can be quite intriguing. In one of our old blogs, we shared a guide on these isolator gloves, and with this blog, we are going to highlight the very purpose of these decontamination systems.
Before we get ahead, we must acquaint ourselves with the two main kinds of isolators and their distinct functions.
Type of Isolators as per Applications
Aseptic Systems – The primary objective of an aseptic system is to provide operators to handle products that demand an aseptic environment wherein sterilized products are filled into pre-sterilized containers with under-regulated air supply and materials, equipment and personnel. In other words, aseptic isolators are used to create a positive pressure environment for non-hazardous material. The aseptic environment is maintained throughout the compounding and material transfer processes by acting as a complete barrier. The modular, closed system protects the sterility of various substances and processes and safeguards operators from low-level cytotoxic materials. The isolator creates HEPA filtered unidirectional flow supply within the work zone and interchange areas, thus assuring ISO Class 5 conditions, continuous sterility and minimization of cross-contamination. These isolators carry out varied functions, viz. sterile drug preparations, sterile injectable drug filling and sterile & pharmacy drug compounding, parenteral processing and filling operations, integration of key monitoring, processing and decontamination systems, automated bio-decontamination and continuous environmental monitoring for maintaining the condition as required. The internal space of the isolator and the exposed surfaces are microbiologically controlled through microbiologically retentive filters, sterilization processes, sporicidal processes (usually by gassing) etc. In addition, the sterile materials are manipulated to minimize the risk of microbiological contamination from the environment. These techniques usually involve eliminating surface-to-surface contacts (except between sterile surfaces), and minimizing the area and duration of exposure.
Non–Aseptic System – These isolators are predominantly meant to protect the personnel and environment from the hazardous or toxic material inside the isolator by creating a negative environment. The non–aseptic nature of drugs necessitates the isolator to adapt to the strict requirements of medical and pharmaceutical processes, which includes antineoplastic, cytotoxic compounding applications and other process-generated particles. Since the negative pressure inside the isolator is lower than its surroundings, in a failure condition, the air would flow into the isolator, but toxic air is not allowed to escape, that is to say, the air is safely retained inside the isolator, therefore protecting the user and the space surrounding the work area.
Fabtech’s GMP standard isolator consists of-
- View/Access panel latches with integrated safety switches
- Engineered filtration system with High-Efficiency Particulate Air (HEPA) inlet
- Unidirectional downflow, return, and exhaust filters
- Positive/negative pressure gradient
- LED lighting system
- Optional accessories, viz. hook on docking bars, welders, cooling trays, and cleaning accessories
All in all, the undesirable but possible absence of isolators may make the entire process prone to failure or could affect the process outcome negatively. Thus, irrespective of their kind, isolators facilitate the protection of the operator and product and preserve its integrity.
A PURPOSEFUL BARRIER OF UNCOMPROMISING SAFETY AND OPTIMUM CONTROL
The basic purpose of isolators:
Containment – The isolator ensures the containment of pharmaceutical processes by promising maximum operation protection. By acting as a physical barrier between the operator and the product, the system guarantees air tightness. It adapts to distinct applications such as Product Transfer, Manual Sampling, and Weighing and Dispensing operations of High Potent Active Pharmaceutical Ingredients (HPAPI). The containment isolators create a negatively pressurized condition and reduced oxygen using inert gases to facilitate a controlled environment. Typical containment isolators are used for low-level cytotoxic or less hazardous products. They are designed with inbuilt capabilities and integrate with new and existing equipment.
To achieve the highest degree of containment, the isolator is responsible for-
· Decontamination by the usage of hydrogen peroxide or H202, a sterilized gas
· High efficiency and maximum product protection through filters
· Elimination of possible contaminants from external environment and operators.
The advantages of Fabtech’s Containment Isolator can be summed up as under:
- Ergonomically designed
- Can be interfaced and integrated with new or existing equipment.
- Accessibility from the initial to the final stage of products.
- Involves low maintenance costs
- Allows the processing of high-level toxic drugs.
Even when products are introduced into the enclosure or extracted, containment must be maintained, and the atmosphere must be preserved from contamination. This is where the transfer lock comes in. This system simplifies not only the transit of products and materials but also the evacuation of waste, thus ensuring that the asepsis of the environment is always respected.
Fabtech’s isolators are versatile to be used for any process in the medical or pharmaceutical sector. We offer custom ISO class 5 standards that exceed the most stringent industry standards and modular or custom-made solutions that answer the requirements and the intended application of your project. This physical barrier promises operator and product protection alike and ensures the integrity of a clean environment with an uncompromising and controlled environment.
We offer complete in-house turnkey design, manufacture, installation, validation and execution of the project. Our offerings include OSD and powder processing, coating and encapsulation. Solutions are available for R&D, pilot and commercial batch sizes. They are validated for OEL compliance post-routine validation.
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