Encap’s cGMP manufacturing facilities includes:

·         15,000 square foot total cleanroom area

·         Dedicated high containment suite

·         High volume manufacturing cleanroom (currently unoccupied)

·         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 volumes

 

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 includes:     

·         4,000 square foot total laboratory area

·         6 HPLC machines, comprising UV, ELSD and RI detection

·         3 Dissolution baths

·         1 Disintegration apparatus

·         1 Karl Fischer Unit

·         1 GC Unit

 

 Encap’s current headcount

·        10         Production

·         8          Analytical chemistry

·         7          Formulation and Process Development

·        13         Quality Control / Quality Assurance

·        16         Other

 

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