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Scandinavian Clinics
Estonia (Steri)
GAMMA STERILIZATION SERVICES
Key Numbers
• Founded - 2005
• 7 employees
• Sales revenue 2015 ca. 800’000.- €
• Treatment volume ca. 600 pallets / month
• Used plant capacity - 50%
Markets
• Sweden 50%
• Finland 25%
• Russia 15%
• Baltics 10%
Largest 3 Customers
• Aurena Laboratories (nasal sprays)
• Thermo Fisher Scientific (laboratory equipment)
• Smurfit Kappa (food packaging)
Location
Kurvi tee 406a, Alliku küla, Saue
vald, Harjumaa 76403, Estonia
25 km from Port ofTallinn
Plant - outside
Plant - Inside
Loadin/unloading station
Tote Boxes
Irradiation chamber structure
Loaded Irradiation chamber
Cobalt 60 sources – „ Cherenkov glow“
Storage area
QUALITY ASSURANCE
• The Quality System ensures that all applicable standards are strictly
followed.These are ISO 9001/2000 (basic Q/A rules), ISO 13485
(special Q/A rules for the medical industry, EN 552 (rules for
irradiation), EN 556 (definition of the term sterility) and ISO 11137
(rules for a/o validation of products). In case of medicinal products,
the rules in the Pharmacopoeia are also applied.The system will also
be compatible with the FDA 21 CFR Part 820 QS Reg. GMP
• We have acquired a cerificate for ISO 13485 (special Q/A rules for the
medical industry that include basic Q/A rules of ISO 9001/2000) with
reference to ISO 11137 (rules for validation of products)
Pricing
• Prices are calculated per container (tote box) and they depend on
needed dose range, product density etc., typically in a range of 40 –
75 €/container (eg. 25 - 125 per m3)
• Dose mappings (product validations) are offered for free for serious
customers. For small volumes the list price is around 400 - 700 € per
product
• Irradiation of samples fee is 175 € per ”reasonable” dose for
"reasonable amount" of samples. "Reasonable" means that weight
must be below 120 kg and samples must fit into one container,
requested dose has usually been in between of 5 kGy and 50 kGy
ThankYou!
TARMO KÕUHKNA

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Scandinavian Clinics Estonia

  • 2. Key Numbers • Founded - 2005 • 7 employees • Sales revenue 2015 ca. 800’000.- € • Treatment volume ca. 600 pallets / month • Used plant capacity - 50%
  • 3. Markets • Sweden 50% • Finland 25% • Russia 15% • Baltics 10%
  • 4. Largest 3 Customers • Aurena Laboratories (nasal sprays) • Thermo Fisher Scientific (laboratory equipment) • Smurfit Kappa (food packaging)
  • 5. Location Kurvi tee 406a, Alliku küla, Saue vald, Harjumaa 76403, Estonia 25 km from Port ofTallinn
  • 12. Cobalt 60 sources – „ Cherenkov glow“
  • 14. QUALITY ASSURANCE • The Quality System ensures that all applicable standards are strictly followed.These are ISO 9001/2000 (basic Q/A rules), ISO 13485 (special Q/A rules for the medical industry, EN 552 (rules for irradiation), EN 556 (definition of the term sterility) and ISO 11137 (rules for a/o validation of products). In case of medicinal products, the rules in the Pharmacopoeia are also applied.The system will also be compatible with the FDA 21 CFR Part 820 QS Reg. GMP • We have acquired a cerificate for ISO 13485 (special Q/A rules for the medical industry that include basic Q/A rules of ISO 9001/2000) with reference to ISO 11137 (rules for validation of products)
  • 15. Pricing • Prices are calculated per container (tote box) and they depend on needed dose range, product density etc., typically in a range of 40 – 75 €/container (eg. 25 - 125 per m3) • Dose mappings (product validations) are offered for free for serious customers. For small volumes the list price is around 400 - 700 € per product • Irradiation of samples fee is 175 € per ”reasonable” dose for "reasonable amount" of samples. "Reasonable" means that weight must be below 120 kg and samples must fit into one container, requested dose has usually been in between of 5 kGy and 50 kGy