At ESFERA we are experts in drug production, from oral to sterile. Liquids, semi-solids: gelatin, ointments, etc. and solids. Our know-how in preparation systems, clean utilities and sterilization of MMPP and product, combined with our many years of experience both as designers and manufacturers of turnkey systems, has allowed us to develop tailor-made solutions for the pharmaceutical and biotechnology industry. in the field of product processing.
We have more than 20 years of experience in the design and construction of critical systems installed in many countries, which have been satisfactorily audited for the local market and for markets such as the United States. (FDA / USP).
What you get after 25 years of experience
Sphere Engineering´s processing plants and systems are fully "in-house" designed and comply with all GMP and ASME BPE standards, ISPE EHEDG recommendations, and are thoroughly tested and qualified.
From conceptual design to SAT after-sales service, and even reengineering, we cover the entire life cycle of your project and accompany you to improve your production.
Stainless steel reactors, Product preparation reactors, pharmaceutical reactor
Our reactor designs have been used for drug production for more than two decades. They are conceived and designed to meet the requirements of each specific customer and to withstand the most hostile conditions (corrosion, ATEX, incorporation of MMPP, high containment, etc.)
Bioreactors and fermentation plants
We are suppliers of the largest manufacturers of API biopharmaceuticals and antibiotics in Spain. Upstream processing involves much more than an isolated microbial fermentation or cell culture equipment.
Sterile addition of culture media and dosing agents should be aseptically fed to the equipment during culture. After cultivation, the product must be harvested, the biological waste inactivated and all sectors - containers and lines must be cleaned and sterilized. Waste must be treated in biowaste systems, there must be effective product control for maximum productivity for subsequent concentration / purification and formulation.
In addition to bioreactors and fermenters, Sphere Engineering also provides solutions for media manufacturing and storage, for continuous sterilization, sterile filtration, CIP, formulation, and inactivation, including liquid transfer and control of all recipe steps.
The portfolio is complete: Buffer tanks, media tanks, inactivation tanks / Killing tanks, bioreactors, microfiltration stations, formulation reactors, CIP systems, agitation. Integration of separation / purification. Even single-use / disposables technology.
Stainless steel tanks, MMPP storage tanks, Aseptic tanks, Product storage and transfer
Take advantage of the experience of Esfera Ingenieria for your storage systems: tanks and product tanks or stainless steel MMPP!
Clean utilities (COMPENDIAL WATERS. PW, WFI, Pure steam)
Water systems for pharmaceutical use: From generation, water distribution loops and pure steam networks, to obtaining the fluid at the point of use, guaranteeing the required quality (compendial Waters) according to international regulations. More than 50 systems installed around the world with a robust operation, validated and successfully audited.
Solutions tailored to requirements. Taylor made systems, from the most conventional designs to innovative solutions such as chemical-free osmosis, ozonation, EDI ...
CLEAN COMPRESSED AIR AND STERILE COMPRESSED AIR
Because both qualities are not the same, we know the implications of the system that your product requires.
ADDITION OF MMPP and STERILIZATION OF PRODUCT OR MMPP
- In liquid phase. Treatment and transfer of MMPP: such as organic solvents, and other liquid chemical agents to be dosed. Its transfer, its aseptic / sterile addition, or even high containment is designed.
- Gases: technical gases, filtration and sterilization of gases, technical gases: from the ramp to the connection to your production equipment, inert gases, etc.
- Pneumatic transport of solids. Solid transfer systems. Solid incorporation systems (dispersers), sieving, grinding. Even high containment systems.
- Dosing in batch or in-line line. Innovative solutions and high performance equipment to optimize the productivity of your plant. High precision dosing.
CIP SYSTEMS
Equipment tailored to your needs:
- On bench
- Docking stations
- CIP Cabinets (closed chamber interior and exterior cleaning)
- Mobile
- CIP / SIP equipment with on-site Sterilization management.
BIOWASTE AND DIGESTORS
Online or batch biocontaminated effluent processing systems. Thermal and / or chemical treatment
CONTROL
It is essential that hydraulic, mechanical and electrical equipment and installations are designed guaranteeing optimal and long-lasting operation, reaching any level of automation desired by our customers.
- PCS7
- SCADA
- MONTH
- ATEX
- ISA 88.1
- Batch recipes .Net systems
- CFR21 Part 11
- Electronic signature
- Tracking and trazability
Quality and documentation
We are aware of the documentation needs necessary in this sector and we offer a sufficient design documentation dossier to satisfy the demands of the most demanding firms in this sector. The articulation of this dossier is that of the large and most prestigious multinational engineering firms.
After installation, a complete as-built dossier is delivered guaranteeing the traceability of parts in contact for a satisfactory validation of all critical systems, cleaning processes, etc. A complete documentary dossier of commissioning from the early FAT phases, exhaustively documents the system up to the SAT and allows a more agile validation with a lower level of deviations.
In addition, if you wish, we validate our process systems DQ design validation, IQ installation validation and OQ operation validation.
At Esfera Ingeniería there is no place for improvisation. Our internal quality system is based on GEP (Good engineering practices) recommendations and ASME (U Stamp) concepts for the construction phase.