Jelfa - Contract medical preparations and packaging

Jelfa Pharmaceutical Company SA is a leading Polish pharmaceutical manufacturer and, since the Polish system of quality assurance is compatible with EU requirements, is a reliable partner as a contract manufacturer. Its production facilities are located in Jelenia Góra, Poland, 60km from the German border and 30km from the Czech Republic. Quality standards comply with international regulatory bodies such as the MHRA, EMEA and the FDA. Key to the quality, efficiency and safety of Jelfa's production are:

• Permanent trained employees
• Simple and clear procedures
• Use of high technology

Jelfa is the biggest manufacturer of ointments in Poland. It is also the leading producer of hormonal and cardiological medicines as well as vitamin preparation. Jelfa is one of the biggest Polish exporters to Russia, Hungary and Ukraine.

Jelfa's portfolio includes over 120 preparations in various forms and doses, such as ointments, creams, gels, suspensions, hard gelatin capsules, tablets, film and sugar-coated tablets, and injection preparation. Production has been fully modernised over the last four years and is divided into three departments.

Ampoules

The ampoules department produces sterile medicine products in solutions, suspensions, powders and lyophilised forms. The department's basic production parameters are for:

• Microcrystalline suspensions: packaged in vials of 2ml, 3ml, 5ml and 10ml; equipment producers: filling machine - Farmomac, sterilising of packages and devices - ICOS and Fedegari
• Lyophilisates: packaged in vials of 3ml, 5ml and 10ml; equipment producers: filling machine - IMA, sterilising tunnel - Libra, lyophilising cabinets - Edwards Kniese
• Ampoules filled with powder: packaged in ampoules of 3ml, 5ml and 10ml; equipment producers: washer and sterilising - Bosch, dosing - EMPAK, welding - ROTA
• Ampoules filled with water or oil solutions: packaged in ampoules of 1ml, 2ml, 3ml, 5ml and 10ml; equipment producers: washer and sterilising - Bosch, dosing - ROTA

The department's packaging parameters are:

• Packing lines - Bosch
• Packing lines in blisters - Marchesini

Ointments

The ointments department produces sterile and non-sterile ointments, creams, gels, liquids, ophthalmic suspensions and emulsions. Its basic production parameters are for:

• Non-sterile glycocorticosteroid preparations: packaged in tubes 10-40g, bottles 15-20ml; equipment producers: - Haagen Rinau, IWK and EMPAK
• Non-sterile preparations non-glycocoticosteroid: packaged in tubes of 3-40g; equipment
• producers - Haagen Rinau and Marchesini
• Sterile glycocorticosteriod preparations: packaged in tubes of 3-15g, equipment producers - Haagen Rinau and Marchesini
• Sterile non-glycocortcosteroid preparations: packaged in tubes of 3-40g; equipment producers - Haagen Rinau and Marchesini

Tablets

The tablets department produces medicines in tablets, film-coated and sugar-coated tablets, lozenges and capsules. Its basic production parameters are:

• Volume - for granulation 40-600kg
• Equipment: granulation - IMA, Vortex for wet granulation and Ghibli fluid bed dryer, Huettlin HMG 600 for wet granulation and HKC 400 fluid bed dryer; tableting machine - Fette, Korsh, Killian; film and sugar coating - IMA GS, Glatt; capsulation - IMA; packing lines - blistering machines: NOAC in blisters PVC/Alu and Alu/Alu - Bosch, IMA, Marchesini in blisters - PVC/Alu

Maintaining standards

Jelfa's quality assurance department, with its permanent trained specialists, is responsible for maintaining its quality standards with the requirements of GMP. The R&D and QC laboratories fulfil world standards in the scope of analyses conduction, validation of analytical methods, certification of quality, contract analyses, making samples for clinical testing, and validation of production processes.

Over 90 specialists are employed in Jelfa's QC laboratories testing the products, the starting components, packages and in microbiological and pharmacological labs. In 2001, it was nominated as the best company in the region and won the Lower Silesian Key to Success award. END