Jelfa Pharmaceutical Company S.A.
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Characteristics of company production departments
• Ampoules Department
The department buildings were thoroughly modernized in the period of 1995-2002.
The Ampoules Department possesses suitable systems of air-conditioning and filtered air intake. The Department has modern devices - Osmotron / Christ to produce purified water, (WFI) / Finn – Aqua and Pharmatec to produce water for injections and
Stilmas device to produce purified steam. These devices cooperate with systems of
storage and distribution made by Axima-Steritec firm.
The Ampoules Department produces sterile medicine products, which due to the character of active substances are divided as follows:
• hormones,
• other preparations.
The products are manufactured in the following drug forms:
• solutions:
- aseptic process,
- thermal sterilization.
• suspensions:
- aseptic process.
• powders:
- aseptic process.
• lyophilized products:
- aseptic process.
Characteristics of main areas of the Ampoules Department
Compartment name Main parameters (purity class)
Compartments for powder dosing Preparation of ampoules - washing (class D),
sterilizing, receipt of sterilized ampoules (class A in surrounding class B)
aseptic pouring, closing and transport (purity class A in surrounding class B)
Compartments for suspensions production Preparation of vials - washing, sterilizing (class D, C and A)
preparation of product in bulk (class C, B and A)
aseptic filling and closing (class A in surrounding class B)
Compartments for solutions production preparation of ampoules, vials - washing, sterilizing (class D, A, B)
preparation of product in bulk (class A in surrounding class B)
aseptic filling and closing (class A in surrounding class B)
ancillary procedures - washing and sterilizing of mixers, sterilizing of filled ampoules (class C and class A in surrounding class B)
Compartments for lyophilized production preparation of vials - washing, sterilizing (class D)
making of solution for lyophilization (class A in surrounding class B)
aseptic filling and partial closing, lyophylization and closing (class A in surrounding class B, class C)
ancillary procedures- washing and sterilizing (class A in surrounding class B, class C)
Compartments for packing in packing compartments there are lines for packing in blisters and in ecological packing, hand packing is also possible
Basic production processes parameters on the Ampoules Department
Production of microcrystalline suspensions
Microcrystaline Suspensions
Package vials
Volume 2 ml - 3ml - 5ml - 10 ml
Standard lot volume in litres 70 - 130
Purity class D, C, B, A
Basic production equipment: Producer:
- filling machine
- sterilizing of packages and devices
Farmomac ICOS ,
Fedegari
Production of lyophilizates
Lyophilizates
Package vials
Volume 3ml - 5ml - 10 ml
Standard lot volume in litres 70 - 150
Purity class D, C, B, A
Basic production equipment: Producer:
- filling machine
- sterilizing tunnel
- lyophilizing cabinets IMA
Libra
Edwards - Kniese
Production of ampoules filled with powder
Powder
Package ampoule
Volume 3ml - 5ml - 10 ml
Standard lot volume in kg 1 - 50
Purity class D, C, B, A
Basic production equipment: Producer:
- washer of ampoules and sterilizing tunnel
- dosing machine
- welding machine Bosch
EMPAK
ROTA
Production of ampoules filled with water or oil solutions
Water or oil solutions
Package ampoule
Volume 1ml - 2ml - 3ml - 5ml - 10ml
Standard lot volume in litres 100 - 300
Purity class D, C, B, A
Basic production equipment: Producer:
- washer of ampoules and sterilizing tunnel
- dosing machine
- welding machine Bosch
ROTA
Other phases of process:
• Sterilizing of full ampoules– Autoclaw Fedegari;
• Optical control – device for automatic optical testing - Eisai;
• Labelling of ampoules, vials – Labeller Libra;
• Tightness control of ampoules- KLD - Bosch
• Packing:
- Packing lines in ecological packing - Bosch;
- Packing lines in blisters - Marchesini;
- Hand packing.
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