Home / PDA Technical Glossary

PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.

(Please select "All" to restart a filtered Search)

Refine Results

Filter By GlossaryTrKeyword

TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

Zone of Protection/Machine Shroud

A system fitted to a BFS machine to direct a flow of HEPA-filtered air over the Critical Processing Zone of the machine. (TR77)

Source:

Static (at rest)

BFS machine line with conveyor belts at rest but with air shower and room ventilation in operation, extruder (heated, not running) and mold carriage in standby. No operating personnel present. (TR77)

Source:

Parison

The “tube” of polymer extruded by the BFS machine from which the containers are formed. (TR77)

Source:

Mandrel

Specialized filling needles on certain BFS machines which also act to form the container. (TR77)

Source:

Dynamic (in operation)

BFS machine line fully operational and filling, with the number of allowed operating personnel present as during normal running conditions. (TR77)

Source:

Air Shower

A device fitted to a BFS machine which provides, at a minimum, a continuous flow of Grade A quality air supply over the filling needles and the point-of-fill. The air shower is also known as a nozzle shroud in shuttle type machines. (TR77)

Source:

Advanced Aseptic Process

A process in which direct intervention with open product containers or exposed product contact surfaces by operators wearing conventional cleanroom garments is not required and never permitted. (TR77)

Source: