Encap's cGMP
manufacturing facilities includes:
-
15,000 square foot total cleanroom area
-
Dedicated high containment suite
-
High volume manufacturing cleanroom
-
3 further capsule liquid filling rooms
-
1 capsule powder filling room
-
2 blisterpacking rooms
-
1 capsule coating room
-
1 GMP development room
Encap's high
containment suite
-
Class 100,000 specification
-
Occupational Exposure Limits (OEL) <0.1 µg
m3
-
100% air extraction, 100% air make up HVAC
system
-
High containment barrier isolator
-
160L mixing vessel
-
Liquid filling machine (40,000 capsules /
hour)
-
Band sealer (70,000 capsules / hour)
Encap's manufacturing
equipment includes:
-
20L sealed and jacketed mixer with paddle and
high-shear
-
200L sealed and jacketed mixer with paddle
and high-shear
-
300L sealed and jacketed mixer with paddle
and high-shear
-
2 x 1500L filling machines (60,000 capsules /
hour)
-
1500L filling machine converted to DuoCap
process (30,000 capsules / hour)
-
2 x Banding machines (70,000 capsules / hour)
-
Powder filling machine
-
Isolation cabinet for pilot scale use
-
Capsule coater
-
Fully automated blisterpacker and cartonner
-
Blisterpacker and cartonner for clinical
trial volume
Encap's intermediate
scale manufacturing equipment includes:
-
1 x Semi-automatic filling and banding
machine (1,000 capsules / hour)
-
2 x Semi automatic capsule filling machine
-
Semi automatic banding machine
Encap also has a wide range of bench scale mixing,
capsule filling and sealing equipment to handle grams of material up to kg scale.
Encap's analytical facilities
include:
-
4,000 square foot total laboratory area
-
10 HPLC machines, comprising UV, ELSD,
fluorescence and RI detection
-
5 Dissolution baths
-
1 Disintegration apparatus
-
1 Karl Fischer Unit
-
1 GC Unit
-
1 FTIR Unit
-
2 UV/Spectrophotometer
Encap's
current headcount
-
12 Production
-
7 Quality
Control
-
6 Quality
Assurance
-
5 Technical
and Engineering Support Services
-
20 Development
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