Key characteristics of Isolator systems for special products

Not all products are equal.

Any product that needs isolator systems is a product that demands the maintenance of specific environments during processing for optimal outcomes. Whether pharma or chemicals or healthcare or nuclear materials, the requirements for each product and industry are unique.

The factors to be maintained (and closely monitored) depend on product property and handling. The most important factors to be considered are:
Amount of heat
Many products are sensitive to heat. This is especially true for vaccines, insulin, derived blood products, oncology products, products for treating glaucoma or auto-immune diseases, biotechnology products, labile blood products (plasma, red blood cells, platelets, whole blood), urine samples, tissue for laboratory use, organs and tissues, etc. [1]

Temperature variations can have significant effects on health products [2]. They can be affected by active ingredient degradation, excipient modification or deterioration of packaging. Temperature impact can make these products unusable, ineffective or even dangerous. In all cases, they lead to increased risks for the patient. [3]

Isolation systems are designed to maintain a suitable climate for the product, to avoid such risks during the manipulation of product inside the isolator. If the product is sensitive to high temperatures, a dedicated air handling unit is provided that can lower the temperature of supply air to a suitable level. The system is actively monitored using temperature sensors inside the isolator chamber to ensure that temperature is maintained within desired limits.

The intensity of light
Light intensity plays an essential role in the workplace. It affects the systolic and diastolic blood pressure, blood oxygen saturation, heart pulse rate and tympanic temperature of people. In the pharma industry, especially, poor lighting can affect the health of workers, causing headaches, eye strain and migraines. As far back as 1987, the UK Government had published a document on the benefits of suitable lighting in the workplace.

In the working area of an isolator, maintaining a minimum of 300 Lux ensures clear visibility and minimises operator fatigue. However, light can also affect products because of the energy it emits. Shorter wavelengths (300mm to 500 mm) exert higher energy which is especially harmful to some pharma products as it breaks down API molecules causing them to degrade. It also catalyses reactions between different chemicals in the product, leading to the formation of new compounds and impurities.

While processing such light-sensitive products, it is vital to avoid interaction with high energy short-wavelength light. At Fabtech, we resolve this issue using an illumination system that emits light of longer wavelength-lower energy to aid the integrity of the product while maintaining the requirement of healthy Lux levels for the operator.

Humidity
When water vapour is present in the air, there is a possibility of product particles attracting and bonding with water molecules from the air at room temperature. This phenomenon, known as hygroscopy, works by either absorbing or adsorbing moisture from atmospheric air and can alter the physical characteristics of the material including changes in volume, boiling point, viscosity, or other physical characteristics or properties of the substance. [4]

Effects of Low Humidity [5]
When relative humidity drops below 45 percent, it causes a static buildup. This accumulation of static charges can dry out medications, affecting intended behaviour of any solvents used in production. Excess static can also cause products to dry out and crumble, or stick together, leading to problems during tablet pressing and packaging.

Effects of High Humidity [5]
High humidity causes products to absorb excess moisture in the air, which can be just as destructive as environments with low humidity. Too much humidity can compromise potency and effectiveness, leading to degradation or even toxicity in some products. The potential for danger is higher when relative humidity levels reach 60 percent or more, allowing viruses, bacteria, mold, fungi and mites to grow.

An overabundance of moisture can also affect production. When products absorb extra moisture, it causes them to either crumble or become sticky, which could clog machinery and bring production to a sudden halt.

Fabtech offers a combination of technologies in the air handling system of isolators that help maintain the desired levels of relative humidity (RH) inside the chamber. This system also actively monitors the climate inside the chamber to make necessary adjustments in RH Value, making it suitable for the product.

Percentage of oxygen
When oxygen reacts with some oxygen-sensitive APIs, it causes the API to degrade, losing effectiveness and making it unusable while forming a byproduct. At Fabtech, we use inert gases inside the chamber, creating a blanket that restricts the percentage of oxygen to specified limits. The system is also self-correcting, using an active feedback loop from in-chamber oxygen sensors that ensure oxygen percentages are always within limits.

Solvent Hazard
Organic compounds – alcohols, ketones, aromatic compounds, nitrates, halogenated hydrocarbons – are widely used as solvents in pharmaceutical and chemical industries. They have a wide range of applications in a pharma setting, including synthesis, extraction, separation, purification and drying, analysis, spectrometric and physicochemical measurements. The hazardous nature of these solvents is determined by danger to person (inhalation exposure, skin absorption propensity) as well as the danger to product (flammability, explosion points)

It is critical to eliminate all forms of risk associated with the use of these hazardous substances in the isolator system from the design phase itself. Fabtech offers a combination of safety features, including Nitrogen blanketing to maintain an inert environment that reduces oxygen percentages, monitored and continuously corrected with feedback loop systems. Electrical systems come with flameproof ratings to eliminate the source of ignition from the system.

At Fabtech, we have designed several custom isolator systems in varying degrees of complexity. Our goal is to deliver an optimal work environment that protects the operator, the product and environment. Use the form below to get in touch with us for a customised solution based on your product properties.

Citations:
[1] Heat-Sensitive Health Products: (http://www.iifiir.org/userfiles/file/publications/notes/NoteTech_30_EN.pdf)
[2] AFF, SFSTP, IIF. Guide pratique de la chaîne du froid des produits de santé. 2008 AFF, SFSTP. Practical guidelines: cold chain for medicine products. 2010
[3] Cavalier G, Boudy V. Practical guidelines for pharmaceuticals cold chain. SMI Pharmaceutical Cold Chain Distribution, London, 1st & 2nd December 2010
[4] Hygroscopy: Wikipedia https://en.wikipedia.org/wiki/Hygroscopy
[5] Effects of Humidity on Pharma Products: http://blog.madgetech.com/the-effects-of-humidity-on-pharmaceuticals