Isolators in pharma are the latest in aseptic processing to provide a barrier between the pharma process, product, and personnel. This article discusses some features of isolators in pharma, and their advantages.
Isolators in pharma are small clean area enclosures that separate the pharma product or process, and personnel. An enclosed system covers a small area, typically standard operating equipment. The enclosed area can be controlled for different physical parameters, such as temperature, pressure, and airflow, according to product and process requirements. The isolator’s main aim is to provide an aseptic barrier between the product and personnel for protection against different hazards.
Some additional features include
- Shoulder high package gloves at one side for material handling
- Transfer system for material entry and exit without breaking the aseptic barriers.
- Ability to produce negative or positive pressure inside the closed area
Advantages of isolators in pharma
Let’s discuss some advantages of isolators in pharma.
Eliminates the need for an HVAC System
Isolators in pharma can provide the required environmental conditions in a small area without making arrangements at the whole room level. This eliminates the need for air conditioning and area control at a large scale.
Isolators fulfil the entire process and product requirements without relying on the room HVAC system.
Pharma Isolators can maintain entire operating conditions just like a room HVAC system. Examples include pressure, temperature, and airflow. It controls these parameters with the highest quality and efficiency.
Reduce environmental monitoring
Environmental monitoring is an essential requirement in the Pharma Industry and determines the quality of a controlled environment. Its main purpose is to ensure that environmental parameters adhere to the standard requirements before starting production.
Isolators in pharma eliminate the environmental monitoring practice because it has already a built-in system of monitoring environmental parameters. It can also record these values in print for later presentation to regulatory bodies.
Reduce clothes changing
In the pharma industry, personnel should change pharma-grade cothes before exposing themselves to a critical area. Because ordinary clothing can become a source of contamination and foreign particles in an aseptic process. Pharma-grade clothing is of high standards that resist the building-up of foreign bodies and contaminants on its surface.
Pharma Isolator minimizes the clothing requirement because all the process occurs in a controlled environment. The personnel can access these processes easily without breaking the aseptic barrier. Material handling and transfer are also performed without requiring personnel to enter or exit the isolator. This automatically reduces the clothing requirement.
Enhanced Operator safety
It is common in Pharma Industry to use toxic and highly reactive products that can become lethalif it comes to human interaction. In an isolator, the barrier between the process and operators ensures enhanced safety of operators. Additionally, gloves also protect operators during material handling.
Operators also remain to save during material entry or exit in the isolator due to the dedicated Material transfer system.
Easy data collection
Environmental Data Collection is a critical requirement for every pharma operation. It ensures suitable process conditions and helps to complete the regulatory compliance requirements.
Pharma isolators provide accurate data collection at regular intervals without human involvement. Different sensors, such as pressure, temperature, and humidity, facilitate this monitoring. The sensor data can be easily retained for record purposes.
Specialized Product requirements
Pharma isolators can also provide operating conditions for sensitive products. It is achievable because isolators only have a smaller area, which becomes easy to control. It also provides a cost-effective product-specific condition without large-scale investment, renovation and amendment.
For example, some Pharma products require low temperatures and light protection for their manufacturing. Pharma isolators can achieve these low temperature or light protection without extra arrangements and resources.
Components of isolators in Pharma
Different components of pharma isolator contribute to its overall performance. Some of them are as follows.
HVAC system
The HVAC system controls different environmental conditions of the isolator, and each isolator has its dedicated HVAC system. The HVAC system takes fresh air from the environment and passes the intake air through the different sections. The air becomes purified as it passes through different sections.
HVAC conditions the incoming air by altering its characteristics, such as temperature and humidity. The conditioned air is used to provide product and process-specific environmental conditions.
An HVAC system is connected to a pharma isolator through the ducting system, which is airtight to prevent air loss and contamination.
Gloves
Gloves are installed at one side of the pharma isolator for material handling. They are sealed to prevent air passage and contamination.
Personnel uses gloves to manage manual tasks, requiring a human environment without compromising septic features.
Validation ports
Validation ports open inside the Pharma isolator to enter different sensors for validation.
They are provided with appropriate couplings that can be sealed. The sealing effect prevents cross-contamination through the validation port.
Transfer system
A transfer system transfers material in and out of the isolator. The main aim of the transfer system is to ensure an aseptic barrier while transferring material from in and outside the pharma isolator.
There are various types of transfer systems and including the following.
- Hinged doors
- Hatchback Windows
- Airlock
- Rapid transfer system
Instrumentation
Instrumentation is used to measure various physical process variables. They send the measured variables to the main controller for further action and processing.
Applications of isolators in pharma
Isolators in pharma can be used for various purposes, depending upon the product and process requirement. However, their main application can be classified into personal and product protection.
Personal protection
Pharma isolators can protect personnel from the toxic effects of the product being processed. It provides a barrier between the personnel and the process and prevents direct interaction of inside air with the personnel.
Personal protection is achieved by negative pressure inside the Pharma isolator that directs the air from the isolator to outside through exhaust. Negative pressure is achieved by running supply year 15 to 30% lower than the exams.
Product protection
Another major application of pharma isolators is product protection. It provides a barrier between the product and the outside environment.
Positive pressure inside the isolator achieves product protection. The positive pressure ensures that the air flows outside the isolator through the exhaust, and the product remains protected without affecting its characteristics. If there is a leak for any reason, contaminated air from the isolator flows outside the isolator, preventing damage to the product.
Supply inlet air at higher levels than the exhaust achieves positive pressure.