For drug manufacturers, protecting products and operators against contamination is a major issue.
The slightest doubt about the integrity or sterility of a batch has serious consequences:
Financial, with the destruction of the incriminated batch and the temporary shutdown of the production line concerned.
Human, sanitary if contamination is not detected in time
On brand awareness
Contamination control also occupies a large place in pharmaceutical GMP (good manufacturing practices).
Barrier technologies (RABS, isolators) meet these challenges. These are safety devices used to protect medicines and pharmaceutical products from contamination and unauthorized manipulation. Their aim is to guarantee the integrity and quality of pharmaceutical products, the protection of patients against potentially dangerous or altered medicines as well as the protection of operators.
In this article, discover how these technologies work, illustrated by 3 use cases.
What is barrier technology?
The definition of barrier technologies
In the pharmaceutical industry, good manufacturing practices (GMP) particularly emphasize the implementation of good practices to avoid contamination. Barrier technologies aim to ensure the protection of sterile production and the management of incoming and outgoing flows.
Concretely, a barrier technology designates a system allowing the process to be separated from the operator in order to:
- Avoid cross contamination
- Separate the space (separate exhaust air/waste exhaust)
- Protect operators in the case of toxic products/containment
- Protect the product
- Allow class skips
Barrier technologies include isolators and RABS.
RABS PASSIVE OPEN
RABS ACTIVE OPEN
RABS ACTIVE CLOSED
ISOLATOR
3 use cases for barrier technologies
Case #1: FCTS – FEDEGARI sterility test isolator
In this first example, the equipment is used to carry out sterility tests on samples from production lines, as part of quality control. The aim is to demonstrate, statistically, that the entire batch is indeed sterile.
According to the isolator principle, the space is separated from the operator. It is equipped with gloves to avoid manipulation by and for the operator.
The system allows decontamination with H2O2 of the entire chamber to work in sterile conditions. It is equipped with an airlock for the entry and exit of equipment. The airlock allows the material to be decontaminated before entering the isolator itself.
Case #2: IPSEN
Here, in the case of IPSEN, the isolator intervenes in the context of hormone production and, more precisely, at the filling stage. The main challenge is to protect the operator from the product, whose active ingredient is extremely powerful. To do this, the system must allow confinement to be maintained throughout the process.
The equipment has been designated for:
Maintain the leak level below 1% vol/h
Meet ISO 14644: 3 classification
Present a chamber pressure of +50Pa +/-10Pa ISO8
This system presents a hybrid operation with:
- An isolated area (in green on the diagram) when in the presence of the product
- A laminar flow zone (in gray) for the entry and exit of the material, with a lower level of confinement
The system plays very finely on aerodynamic parameters to maintain the desired level of confinement from one zone to another, in an environment generally in depression. Air barriers, placed between the compartments, make it possible to maintain the pressure differential between neighboring compartments.
Case #3: Central Pharmacy of the Armed Forces
The third case corresponds to a production line that involves several types of containers: cartridges, syringes, vials.
The PCA production line is L-shaped with a series of compartments. Between them, these compartments are linked by a pressure cascade.
The insulator will ensure the sterility of the product precisely because manufacturing takes place in an overpressure environment which protects it from external contaminants.
In this system, certain compartments will be used specifically depending on the type of container to be produced.
