SPECTRUM PHARMATECH CONSULTANTS - NEW COMPANY PROFILE

Case Studies
Finished Dosage Forms
LARGE VOLUME PARENTERALS FACILITY
JSC Eastpharm, Vladivostok, Russia
The project involved setting up facility for producing Large
Volume Parenterals and associated testing laboratories at
Vladvostok in Russia. The facility was planned in accordance to
cGMP requirements of WHO.
SPECTRUM was involved in sizing and selection of process
Detail Engineering
equipment and SPECTRUM's scope included developing
Procurement Assistance
concept designs, basic engineering and detailed engineering.
Construction Management
Systems such as Modular Clean room panels, HVAC, Process
Validation Assistance
Equipment, Generation and Distribution systems for Purified
Water, WFI, Pure Steam were supplied from India.
Phase I of the project, has an annual installed capacity of 12 Million bottles of 500 ml fill volume whereas the Phase II of the project
augmented the annual capacity by additional 8 Million bottles of 100 ml fill volume.
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SVP with BFS MACHINE, PENICILLIN & CEPHALOSPORIN DRY
POWDER INJECTABLES FACILITY and GENERAL ORAL SOLIDS FACILITY
SCOPE OF SERVICES:
Concept Design
Basic Engineering
Detail Engineering
Procurement Assistance
SCOPE OF SERVICES:
Concept Design
Basic Engineering
JSC Pharmasyntez, Irkutsk, Russia
The project involved setting up facilities for manufacturing SVP with BFS
machine for Water for Injection & Opthalmic products, General Oral
Solids, Penicillin Dry Powder Injectables and Cephalosporin Dry Powder
Injectables. The facilities were planned in an existing building and were
set up in accordance to cGMP requirements of WHO.
Unique feature of engineering was design of HVAC systems for sub-zero
temperatures of up to (– 40) deg.C. This required Humidification as the
humidity levels would fall to very low levels during winters. Systems such
as HVAC, Process Equipment, Generation and Distribution systems for
Purified Water, WFI, Pure Steam were supplied from India.
The project provided insight in to how project were executed in countries
of erstwhile Soviet Republic. It would typically involve preparing and
submitting project drawings and documents to a local project institute
who were the only ones authorized to design projects in Russia. The
institute would then translate all drawings in local language and then
issue the same to contractors for execution.
We have installed Rommelag 321 for manufacturing of ampoules for Water for Injection and ophthalmic products with BFS
technology. Machine has annual output 12.0 Million with one shift a day.