Warehousing of Starting Materials
- A 4000 m2 temperature controlled environment
- Exceptionally clean and orderly at all times
- Well trained staff with experience in FIFO and care in handing pharmaceuticals
- HEPA filtered dehumidified air servicing a 4 stage sampling booth
- GWP practiced at all times
Laboratory Testing
- A large modern temperature controlled laboratory with 12 staff
- Provides starting materials and lot release testing for production
- Provides Total Organic Carbon testing for production cleaning validations and water analysis
- Full ambient, accelerated and retention sample storage suites
- Test equipment includes HPLC, TOC, UV Spec, Karl Fischer, FTIR, Automatic Titrator, Drying Oven, Refractometer, Melting point Apparatus
- Fire proof storage of archives and regulatory documentation
Dispensing and Blending
- A modern 3 stage dispensing facility with HEPA filtered dehumidified air and centralised vacuum
Hard Gelatine Encapsulation
- 2 Modern GMP fully automated capsules filling lines
- Hard Gelatine or Vegicaps or Delayed Release caps
- Capacity 2.5 million hard gel caps per day (size 1, 0, and 00
- Batch size capability – 600 000 capsules to 10 000 000 capsules per batch
Tableting
- Three modern GMP design ‘B” type , 20, 37 and 40 Station compression presses.
- Capacity 2 000 000 tablets on a single tip punch per day
Powder and “Stick” Sachet Packing
- 2 automatic high speed GMP lines
- Nitrogen flushing, individual stick batching, non-fill detection, easy tear notch
- Line 1 consists of a 8 lane stand-alone machine:
-4 x 15 lane stick pack machines, linked to 2 automatic pouch packing machines.
- Line 2 consists of 2 x 15 lane stick pack machines, linked to automatic pouch and/or carton packing equipment:
– High speed fully automatic filling and packing of sticks into batched and branded pouches and cartons
-Capacity 1680 000 sticks per day
– Batch sizes 4 000 000 sticks upwards
Blistering
- 2 GMP Rotary blister machines
- Each machine fitted with inline X-Ray equipment
- Multi tablet blisters or single blisters
- Wide range of tooling to suit most tablets / capsules / soft gels
- Able to run PVC – aluminium foil or PVC/PVDC – aluminium foil blisters
- Combined Capacity of 110 000 blisters per day
Tablet Counting into Containers
- 3 fully automatic GMP counting lines
- Lines include automatic cappers, desiccant and foam insertion, induction sealers, labellers, ink jet coders, and shrink wrappers
- Able to count any tablet, capsule or soft gel
- Able to handle a wide variety of container types and shapes
- Combined capacity 70 000 containers per day
Aerosol Filling
- A dedicated GMP area licenced to fill topical pharmaceutical aerosols
- Unmanned gassing station linked to filler and capper by conveying
- Ink jet batching, water bath testing and shrink wrapping
- Capacity 30 000 aerosols a day
Liquid Manufacture and Filling
- Liquid manufacture area with RO water plant, homogeniser, heating vessels, and shearer
- Suited to the manufacture of solutions such as nasal drops and sprays
- Mobile 2500L tank feed the liquid line.
- 4 headed liquid filler with labeler and cartoner
- Capacity 24 000 units a day
