The need for contained handling and processing of pharmaceuticals started to rise significantly about 15 years ago. The main reason for this was an increased focus on health and safety aspects as well as the development of more potent pharmaceutical ingredients.
The response by the pharmaceutical equipment suppliers has resulted in market improvements in the containment levels achievable, using both established techniques as well as and new equipment and innovative solutions.
The selection of suitable equipment at the right place however requires an in depth understanding of certain containment aspects. Firstly to assure that the chosen equipment performs in the required level, but also, and this is important from the investment aspect, to prevent an expensive and unnecessary potential "Overkill".
What is Containment and why do we need Containment? Basically, containment is the separation from product to personnel (environmental) by a barrier. Containment is needed to prevent any negative impacts (contamination) from one area to the other and vice versa.
Potential contamination sources:
The personal protection aspect however has always to be considered as the more important one, as human health can't be replaced in any way. That means that the first duty of every employer is to prevent the exposure of employees to substances hazardous to their health. However the reality shows, that exposure can't be fully prevented by equipment. Therefore the employer has to ensure by using suitable equipment, that the real equipment exposure is lower than a product (API) specific Exposure Limit. How do we have to understand now a product specific Exposure Limit or a real equipment exposure?
As exposure can't be fully prevented the company has to ensure by using suitable EQUIPMENT, that the OPERATOR's Real Daily Intake (RDI) of a hazardous substance doesn't exceed the PRODUCT specific Acceptable Daily Intake (ADI)
RDI < = ADI
|Hierarchy of Control|
|Ventilation / Extraction|
|Standard Operation Procedures (SOP)|
|Last Resort||or combination of the above|
Production areas that typically require High Containment Interfaces includes:
Buck® Valve components are dedicated to all pharmaceutical production processes such as API production or production of final oral dosage form as well.
To see typical process interfaces where Buck® Valve High Containment Interfaces technologies are required please access the following GEA Pharma Systems page: "Technologies that typically require High Containment Interfaces."