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Manufacturing Equipment List

Product Type
Equipment
Per Batch Scale (Max.)
Standard
Standard Products
Intravenous Solutions (Aseptically Prepared)
Manual Operation in a VHP sterilised Isolator (Grade A Environment in a C room)
~200 units
GMP
Oral Solutions
ESCO EL20, L5T/AX5 Silverson Blenders, Heidolph Stirrers, Accuramatic and Peristalic pumps
~20 litres
GMP
Oral Suspensions
ESCO EL20, L5T/AX5 Silverson Blenders, Heidolph Stirrers, Accuramatic and Peristalic pumps
~20 litres
GMP
Oral Emulsions
ESCO EL20, L5T/AX5 Silverson Blenders, Heidolph Stirrers, Accuramatic and Peristalic pumps
~20 litres
GMP
Formulated Capsule (Dry Blend)
Turbula Blender with manual or semi-automated filling
~0.5 kg
GMP
Formulated Capsule (Semi-Solid Matrix/Hard Gel Capsule)
Manual Operation (Conducted in an MSC)
~200 units
GMP
Comparator Products (Capsules)
Quantos Powder Dispensing System
~1000 units
GMP
API in a Capsule
2 x Quantos Powder Dispensing Systems
~1000 units
GMP
API in a Capsule
Capsugel Xceldose® 600S Precision Powder Micro-Dosing Systems
~5000 units
GMP
API in a Vial
2 x Quantos Powder Dispensing Systems
~1000 units
GMP
Nano Suspensions
U.S. Stoneware Roller Mill; IKA Vertical Mill; Emulsiflex C5 high pressure homogenisers
~1000 ml
GMP
Radiolabelled Products
Radiolabelled Intravenous Solutions (Aseptically Prepared)
Manual Operation in a VHP sterilised Isolator (Grade A Environment in a Grade C room)
~200 units
GMP
Oral Solutions
Manual Operation (Conducted in an MSC)
~200 units
GMP
Formulated Capsule (Semi-Solid Matrix)
Manual Operation (Conducted in an MSC)
~200 units
GMP
API in a Capsule
Manual Operation (Conducted in an MSC)
~1000 units
GMP
API in a Vial (Radiolabelled)
Manual Operation (Conducted in an MSC)
~200 units
GMP
Nano Suspensions
U.S. Stoneware Roller Mill; IKA Vertical Mill; Emulsiflex C5 high pressure homogenisers
~1000 ml
GMP
Cytotoxic Products
Cytotoxic Intraveneous Solutions (Asptically Prepared)
Manual Operation in a VHP sterilised Isolator (Grade A Environment in a Grade C room)
~200 units
GMP
API in a Capsule
Manual Operation (Conducted in an Isolator)
~1000 units
GMP
API in a Vial (Cytotoxic)
Manual Operation (Conducted in an Isolator)
~200 units
GMP
Nano Suspensions
U.S. Stoneware Roller Mill and IKA Vertical Mill
~250 ml
GMP
Correct as at 25-Jun-2019