Uniqueness of ESKAYEF Oncology Facility
The state-of-the-art facility of ESKAYEF Oncology has been developed by the technical collaboration with Telstar, A Europe-based global leader in providing life science solutions.
It is situated at Murapara, Rupganj , Narayangonj. The facility has the flexibility and capacity to undertake formulation, compounding and filling of a wide range of oncology products (such as liquid and lyophilized injectables, tablets and capsules).
Location at Rupganj
12,000 SFT production floor
Highly automated production lines
Developed by renowned Spain based consultancy firm
Developed through Technical Collaboration with Telstar; a Europe-based global leader in providing life science solutions.
First time in the history of Bangladesh, ESKAYEF Oncology facility has been built with the most advanced ISOLATOR TECNOLOGY.
First time in Bangladesh true OEL validated Oncology facility and in compliance with all the major global regulatory authorities like FDA, MHRA, TGA, WHO and EUROPEAN MEDICINE AGENCY.
Compliance
This facility complies with all the stringent guidelines of global regulatory authorities like US FDA, UK MHRA, EU EMA, WHO GMP.
World Class Manufacturing Facility
with Isolator Technology
Isolator technology has been applied in every step of manufacturing process of tablets, liquid injections and lyophilized Injections to ensure the safety of people and to avoid Cross Contamination of Oncology Products.
Unique Isolator Technology for Solid Dosage Form
Dispensing Isolator (Topleader, China)
Tablet Press (Telstar, UK)
Granulation Suite (Cosmec, Italy)
Coating (Xiaolun, China)
Unique Isolator Technology for Injectable Dosage Form
Sterile Liquid Filling
Autoclave
Lyophilizer
Dry Heat Sterilizer
Injectable Dose
- Formulation Tanks
- Autoclave
- Dry Heat Sterilizer
- Vial Filling With Isolator
- Vial Wash External
- Lyophilizer
Oral Solid Dose
- Dispensing isolator
- Granulation Unit with isolator
- Tablet Compression with isolator
- Coating with isolator
OEL Validated Oncology Facility
OEL, or Occupational Exposure Limit is an upper limit of the acceptable concentration of a hazardous substance in workplace air.
First time in Bangladesh, Zero level of surrogate material was observed in breathing zone at working area of Eskayef Oncology plant. The controlled system and OEL performance test revealed, people working inside the facility is safe, even if they wear normal gown.
" Eskayef Oncology is the only company in Bangladesh and very few companies in the world, which successfully completed true OEL Validation as per ISPE (International Standard of pharmaceutical engineering).
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PREMIUM QUALITY
RAW MATERIALS FROM EUROPE
All the Raw Materials of ESKAYEF Oncology Products are sourced from different European countries.
COS* & US DMF* Grade API are used in ESKAYEF Oncology products.
Safety
To ensure occupational safety, Eskayef is the only company in Bangladesh to successfully complete true OEL (Occupational exposure limit) Validation as per ISPE. Some of the features are Pal in pal out is used for entry and exit which protects different work zones, Bubble and sink technique is used in airlock- prevents contamination, Delay timing interlock doors refreshes contaminated air, Dedicated water distribution ensures integrity of products and H14 HEPA filter is used in HVAC and exhaust that guarantees pure air.
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