Isolators In Pharma Industry

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Isolators In Pharma Industry

Isolators are clean air devices providing complete separation between an aseptic process (hazardous/non-hazardous), the technical personnel, and the surrounding work environment. Isolators are generally used in applications requiring a high degree of protection from external elements or contaminants, and they can serve as alternatives to sophisticated cleanrooms.

Isolators typically feature built-in air filtration systems capable of significantly lowering the particle count in an enclosed area. The relatively compact size of the isolator’s interior makes it easier to clean with gas or vapor sterilizing agents. Isolators can be configured to have either positive or negative pressure relative to the surrounding environment depending on the application.

Positive pressure isolators provide product protection against contaminants, hence maintaining sterility.

Negative pressure isolators, provide personnel and or environmental protection by containing the hazardous or toxic materials inside the isolator.

The isolator is a device designed to create a physical barrier between the operator and the product. It plays an important role in the chemical or Pharma Industry as it helps to keep your Chemicals from reacting with each other. There are some chemicals or inert gas which if reacted with the product can alter the efficiency of the chemicals. Therefore the isolators play a role here. There are various types of isolators being used in pharmaceutical companies known as Pharmaceutical Isolators that are discussed in the latter part of the article.

Isolators

TYPES OF ISOLATORS USED IN THE PHARMACEUTICAL INDUSTRY

  • Aseptic Isolators
  • Formulation and Filling Line Isolator
  • Containment Isolators
  • Bio Isolators
  • Class III BSC-Configured Isolators
  • Hospital Compounding Isolators
  • Cell Processing Isolator (CPI)

Aseptic Isolators

Also known as a laminar flow glovebox isolator, this type of containment isolators helps technicians in the safe handling of materials during the compounding and material transfer because of the presence of the complete barrier in between. A series of HEPA filters keep a tab on contaminated air from getting recirculated back into the lab.

The aseptic isolators can be used for non-hazardous and hazardous materials and provide a clean and safe atmosphere. A compounding aseptic containment isolator is additively used while working with hazardous material to create a negative pressure controlled environment while handling non hazardous material, a compounding aseptic isolator is used in order to create a positive pressure inside.

Aseptic Isolators are critical for the provision of an isolated ISO Class 5/Grade A environment required for the manufacture of sterile products and for carrying out aseptic processes. These types of isolators can carry out automated pressure hold tests, automated bio-decontamination, and continuous environmental monitoring to ensure the maintenance of the required condition.

Applications of Isolators

  • Cell Therapy/Bioprocessing/Cell
  • Electronics/Semi-conductors Production
  • Pharmaceutical Manufacturing
  • Research and Development
  • Sterility Testing

Formulation and Filling Line Isolator

cGMP-compliant isolators and high-quality filling line accessories/technologies, to ensure product safety and sterility throughout the entire manufacturing cycle.

Enclosure systems for this technology can range from open and closed Restricted Access Barrier Systems (o/cRABS) to leak-tight isolation technologies compliant with international GMP standards.

Containment Isolators

The containment isolators have been designed to create a physical barrier between the product and the operators so as to create a controlled environment having negatively pressurized conditions with reduced oxygen. This condition has been achieved using inert gas. A typical containment isolators are used for low level cytotoxic or products that are less hazardous. They are designed with inbuilt capabilities and integrate with new and existing equipment.

Containment Isolators are often designed with a negatively pressured system for the containment of the environment used for processing hazardous products and highly potent active pharmaceutical ingredients (HPAPIs). This type of isolator is typically in turbulent airflow, capable of carrying out automated pressure hold test, with breach compensatory mechanism to prevent the escape of the hazardous product. In this type of system, operator protection is the priority!

Applications

  • HPAPIs and Potent Powder Handling
  • Pharmaceutical Manufacturing
  • Research and Development
  • Weighing and Dispensing of Powders/Excipients

BIO ISOLATORS

Biological isolator or safety cabinets are commonly used in pathology labs or research labs where it is needed to work with pathogenic microorganisms, human or animal tissue, DNA isolation techniques, etc. These cabinets come with laminar airflow filters to protect the lab workers from getting exposed to such degrees of biohazards. Depending upon the degree of hazard, these isolators have been categorized into three classes I, II and III. Class III is considered to be the safest of all as it can work at the level of microscopic organisms.

Class III BSC-Configured Isolators

Class III BSC-configured isolators are configured to operate as a Class III Biological Safety Cabinet. A Class III BSC is a closed-system airflow cabinet designed to provide protection from biohazards by maintaining negative pressure inside the cabinet and providing a rigid leak-tight physical barrier between the worker and the source of the biohazard.

Applications

  • Cell Processing/Bioprocessing/Cell Cultures
  • Laboratory containment for handling biological agents of up to level 4
  • Research and Development
  • Virus and Vaccine Production

Hospital Compounding Isolators

Isolators are now being increasingly utilized for Pharmacy Compounding applications. In the United States Pharmacopeia, two (2) types of isolators are being described for this process:

  • Compounding Aseptic Isolator (CAI) – provides a safe and clean environment for compounding of non-hazardous, sterile drug preparations and IV admixtures in compliance with USP <797> criteria.
  • Compounding Aseptic Containment Isolator (CACI) – provides a safe and clean environment for compounding of hazardous drug preparations in compliance with USP <797> and <800> criteria. It is suitable for work involving hazardous materials, antineoplastic, or cytotoxic compounding applications.

Applications

  • Chemotherapy/Hazardous Drug Handling
  • Cosmetics/Cosmeceuticals
  • Research and Development
  • Sterile/Aseptic Compounding
  • TPN Formulation and Compounding

Cell Processing Isolator (CPI)

Cell Processing Isolator (CPI) is an integrated system that combines several types of equipment into one isolation technology. It is designed to isolate the process to ensure operator safety without compromising product quality. It also provides a sterile ISO Class 5/Grade A environment that is required to carry out aseptic processes.

Applications

  • Allogenic Cell Therapy
  • Aseptic Processing
  • Autologous Cell Therapy
  • Cell Banking
  • Cell Processing
  • cGMP Manufacturing
  • Monoclonal Antibody Production
  • Vaccine Research
  • Virus Production