C
cGMP Manufacturing
Current Good Manufacturing Practice.
Local Context (Ireland/EU): Regulations enforcing proper design, monitoring, and control of manufacturing facilities and processes. Audited directly by the HPRA.
CIP Manufacturing
Clean-in-Place.
Local Context (Ireland/EU): An automated method of cleaning the interior surfaces of pipes, vessels, process equipment, and filters without disassembly.
D
Downstream Processing Manufacturing
The purification and recovery of product from cell culture fluid or biological harvests.
Local Context (Ireland/EU): Utilizes filtration, chromatography, and viral inactivation steps to isolate pure proteins.
G
Grade A Manufacturing
The high-risk cleanroom grade for aseptic operations, requiring laminar flow and near-zero particle counts.
Local Context (Ireland/EU): Regulated under EU GMP Annex 1, requiring active microbial and physical monitoring during all filling processes.
Grade B Manufacturing
The background environment cleanroom grade for Grade A zones in aseptic preparation and filling.
Local Context (Ireland/EU): Requires strict personnel gowning and gown validation before entering.
Grade C Manufacturing
Cleanroom grade used for less critical stages of manufacturing, such as preparation of solutions to be filtered.
Local Context (Ireland/EU): Requires controlled access and cleanroom clothing standards.
Grade D Manufacturing
Cleanroom grade used for handling less critical materials and equipment cleaning operations.
Local Context (Ireland/EU): Acts as the entry barrier cleanroom classification in most Irish biopharma plants.
H
HVAC Manufacturing
Heating, Ventilation, and Air Conditioning.
Local Context (Ireland/EU): Cleanroom air handling systems that control temperature, humidity, and particle counts, using HEPA filters to prevent product contamination.
L
Lyophilisation Manufacturing
Freeze-drying. A low-temperature dehydration process that involves freezing the product, lowering pressure, then removing ice by sublimation.
Local Context (Ireland/EU): Highly utilized in Ireland for packaging and stabilizing delicate protein and biologic therapies.
S
Serialization Manufacturing
The process of printing unique 2D barcodes and serial numbers on medicine packages for trace-and-track validation.
Local Context (Ireland/EU): Mandated in the EU by the Falsified Medicines Directive (FMD) to secure the distribution supply chain.
Single-Use Technology Manufacturing
Disposable manufacturing equipment components (such as bags and connectors) used in place of traditional stainless steel.
Local Context (Ireland/EU): Reduces cross-contamination risks and cleaning validation requirements in biopharma facilities.
SIP Manufacturing
Sterilize-in-Place / Steam-in-Place.
Local Context (Ireland/EU): An automated thermal method of sterilizing process lines and bioreactors using saturated steam without disassembling the system.
U
Upstream Processing Manufacturing
The initial stages of bioprocessing including cell line selection, media preparation, cell inoculation, and growth in bioreactors.
Local Context (Ireland/EU): Focuses on optimizing yields before cell harvest and purification.