Key directions

Tablets

Infusions

Ampules

Localization in POLYSAN sites

Full production cycle for finished dosage forms and the possibility of final synthesis and API treatment stages

Dosage forms

Coated or uncoated tablets (including oblongs)

Infusion solutions, peroral solutions, peroral suspensions

intravenous and intramuscular solutions

Dosage forms (including tablet form and design) may vary; additional requirements and descriptions should be provided

Max. production capacities

300 mio tablets/year

7 mio polymeric containers/year

50 mio ampules/year

API requirements

Products that require no dedicated production area (ref. Russian Federation Governmental Decree No.686 as of July 06, 2012)

Packaging

Blister PVC/Al, PVC, PVDC/Al, Al/Al (blister requirements should be provided)

Polypropylene film bags 5000, 1000, 500, 250 and 100 ml with 1 or 2 SFC ports; bicolored data printing is available

Ampules 2, 5,10 and 20 ml

Printing of track and trace data required for serialization and aggregation (ref. Russian Federation Governmental Decree No.62 as of January 24, 2017) Application of tamper-evidence stickers to the secondary packaging

Sterilization requirements

-

1. Production of DP that require final sterilization
2. Technical capacities to arrange aseptic filling (ampules)

Storage conditions

No cold chain

Specific requirements

POLYSAN doesn’t manufacture cytostatic products (current operations are with APIs that are not higher than OEB III and III toxicity class in accordance with GOST 32419-2013) involving existing production lines; no operations presuming high dust/vapors/gas formation and involving explosive and fire hazardous substances.

Occupational safety requirements

API OEB – not higher than III

Equipment cleaning requirements

Existing production lines are cleaned within standard cleaning procedures using CIP/SIP or WIP stations and pharma-friendly detergents (alkaline, acid)

Requirements to components

For existing production lines: oil-free, no ethyl alcohol

Waste disposal

Wastes of 3-5 hazard categories