Have a requirement?
Chat with us
Have a requirement?
Chat with us
DESIGN AND VALIDATION
With decades of industry experience and hundreds of successes, Biopharmax positioned itself as one of the world leaders in design and validation of biopharmaceutical facilities. By utilizing its in house capabilities, Biopharmax provides the complete design and validation range to comply with manufacturing facility requirements. Our global staff includes seasoned designers with unique experience in the Biopharmaceutical industry. New recruits are chosen from the best technical schools and trained by Biopharmax training department, based on programs developed relying on experience derived from hundreds of projects successes. While performing the design tasks we utilize the latest design tools and maintain the highest engineering standards. Biopharmax is committed to comply with cGMP as required by the various regulatory authorities, both local and FDA / EMEA. |
Validation Master Plan
Get Latest Price
Validation Master Plan (VMP) - definitions of purpose, scope, standards, guidelines, documentation, manufacturing process, facility description, equipment cleaning methodology, computerized systems process etc.
Pre-construction meeting when applicable - to pre approve the design
Design Qualification (DQ) - design compliance to URS
Installation Qualification (IQ) - proper systems installation
Operation Qualification (OQ) - proper systems operation
Production Qualification (PQ) - support our clients with production
Early validation testing to ensure compliance with local health authorities, FDA and EMEA approval with no or minimal remarks
View Complete Details
House design capabilities
Get Latest Price
View Complete Details
Biopharmax Automation Solutions
Get Latest Price
Redundancy PC/PLC control approach
Experience with all PLC / SCADA platforms
User friendly HMI tailor made to project needs
PLC communication with plant database
Online fault signaling and remote location control
Historical reporting databas
View Complete Details
PROCESS OPTIMIZATION
Get Latest Price
Biopharmax multi-disciplinary in house team of experts initially thoroughly studies the project's requirements by ways of design workshops and discussions with the client, sharing the accumulated know how. After acquiring in-depth understanding of the process and other project requirements Biopharmax can assist in compilation of the URS. Early stage planning by Biopharmax process department usually results in a compact design with optimal man material flow, simplified layout and minimal footprint - to support project cost reduction. | Our team is always striving to optimize the process to achieve improved yield and reduced cycle time while maintaining the reliability of the process. By optimizing the process and designing the manufacturing facility in accordance to the improved manufacturing technologies, project CAPEX is often reduced and more importantly operating expenses are capped to increase project IRR. |
View Complete Details
SCALE UP
Get Latest Price
The multidisciplinary process expertise accumulated by Biopharmax team, as well as the project hands on experience alongside the early stage our clients start their discussion with us, allows Biopharmax to contribute to our client's successful scale up.
Biopharmax ensures anticipation of all possible constraints starting from design and associated costs, through raw materials usage up to regulatory, resulting in achieving the efficiencies anticipated from the scaled up process and often improving them.
Biopharmax undertakes and guarantees the commercial manufacturing facility regulatory approval and supports compliance of the product, after scale up, to the qualification and regulatory approval.
Biopharmax develops and constantly improves manufacturing technologies to support commercial scale manufacturing; this flexibility allows our clients to achieve successful manufacturing
View Complete Details
AUTOMATION & CONTROL
Get Latest Price
The programming, simulation and software running are performed under strict quality assurance procedures adhering to CFR 21 Part 11, GAMP 5, and S88 to comply with the rigorous requirements of the most advanced regulatory authorities. |
View Complete Details
REGULATORY COMPLIANCE AND VALIDATION
Get Latest Price
As the regulatory requirements and supporting documentation increase year by year, so does the level of expertise required to ensure Biopharmaceutical manufacturing facility compliance.
Regulatory approval is a core driver to Biopharmax design, and the validation process is seamlessly integrated throughout the project life cycle.
Biopharmax commits to successful approval for all facilities we design and build; we make it a point to ensure smooth and fast plant approval. We have successfully completed facilities approval in over twenty countries, including local health authorities and FDA / EMEA / SFDA / Indian cGMP / local MoH / WHO and others.
More importantly the approval process for these facilities was fast and with minimal remarks, enabling smooth transition into commercial manufacturing.
We were able to achieve this success due to our in depth industry understanding and our in house integration between the departments. Biopharmax developed a unique validation methodology designated to comply with our turnkey model. The validation process, preformed by Biopharmax validation department and coordinated with all relevant departments, starts at the very early steps of the design or even as early as the URS stage.
We team up with our clients to create an elaborated VMP (validation master plan) ensuring the appropriate regulatory requirements definitions. We than ensure the design and the execution on site are compliant in every step of the project. As the project progress, Biopharmax performs all DQ/IQ/OQ/PQ tasks in coordination with our clients.
When possible, and in an early project design stage, Biopharmax will participate in pre-construction meetings with the regulator to minimize uncertainties.
Finally we prepare our client for authorities' approval. We work closely with all our clients' relevant departments and coordinate validation design and documentation. This is performed throughout all project lifecycle, and supported by Biopharmax after project is successfully validated.
View Complete Details
Plant Integration
Get Latest Price
In order to achieve an optimal plant integration, Biopharmax process design department coordinates the design, validation and automation requirements and follows throughout the project life cycle on the compliance.
Biopharmax dedicated software and automation department employ the best programmers and engineers with Bio pharmaceutical unique expertise, since Biopharmax operates only in the Bio pharmaceutical space, our automation solutions are of the highest standards and the most advanced in the industry
View Complete Details
need
details