Grindeks offers Contract manufacturing services for manufacturing of final dosage forms of various volumes that is possible depending on the client’s needs:
Products in tablets and capsules can be produced in the way of wet granulation (in the high shear mixer or/and fluid bed dryer) or by dry mixing technology.
After powder pressing / filling in capsules, in-line deducting of tablets/capsules and metal detection is carried out.
For coated tablets both, water and ethanol-based solutions can be used.
Tablets, coated tablets, capsules will be packed in blisters or in plastic containers. Primary packaging is separated from secondary packaging. All operations with the open product, including primary packaging are carried out in D cleanness class room.
- Variety of forms – round, oval, with break-line
- Sizes – 5-12mm
- Coating with film possible (both – water and organic solvents)
Hard gelatin capsules
- 3, 1, 0, 00, 2, 4
- Variety of colours
Blister packaging and cartons
- PVC, PVCD/ALU, ALU/ALU blisters
- 6-25 tablets and 6-10 capsules per blister
- 1-10 blisters per box
Plastic containers with labels and cartons
- Volumes – 15ml, 50ml, 75ml, 100ml, 200ml with flip-off cap
Main supplier – Gerresheimer AG (Material: container HDPE, cap LDPE, Snap lock system, Wide neck design, Handy Cap easy-open system)
Cytostatic medicines in finished dosage forms (capsules) are produced and packaged in a separate, specifically reserved manufacturing unit;
Mass preparation for manufacturing of capsules is available only with dry mixing technology.
Hard gelatin capsules
- 0; 1; 2; 3; 4
Packaging for finished Cytostatic products can be made either in PVC, PVCD/ALU blisters or in plastic (HDPE) containers
Following products can be produced in the unit: emulsion ointments, suspension-type ointments, based on fat, as well as different water and ethanol based gels with density from 0.800 to 1.100 kg/m3 and viscosity 6.000 – 36.000 mPas.
In plastic or aluminum tubes with leaflets and cartons
- Tubes: 93-165 mm
- 2-250 ml
Technological process is highly automated. All process vessels and both homogenising units are equipped with automatic powdered raw material vacuum loading, automatic water purification and ethanol dosing, and process control computer.
The maximum production capacity depending on viscosity is 200L or 1000L, and minimum depending on the viscosity is 45L or 200L.
Theoretical mechanical capacity of the filling equipment is up to 180 tubes/minute.
Filling line is equipped with two-way automatic 100% weighing of the filled tubes and with feedback site and controlling computer.
Automatic packaging of the filled tubes in cardboard boxes along with instructions. Cardboard machine is equipped with a serial number and expiration date printer, a control computer, and FARM code packets and instructions readers for use. Theoretical mechanical capacity of the equipment is up to 190 packets per minute.
The syrup production section of the Final Dosage Form Production Division produces:
100L, 220L and 500L liquid oral dosage forms production at room temperature;
The resulting solution is filtered through a cartridge filter – pre-filter: 0.45 mcm main filter: 0.22 mcm – and filled into 30-260 mL glass or plastic bottles.
Plastic and glass bottles with labels, leaflets and cartons.
- Volume 26-260 ml
- Height 20-150 mm
Main supplier for Syrup bottles (glass) – Gerresheimer AG.
Packaging process is manual – labels and boxes stamping, box folding, label affixing, bottle packaging and bulk packaging handling;
The unit capacity, working in one shift is 500 000 bottles (100 mL) per year.