BioAspire Process Solution is part of the 31 year old Vyankatesh Fabrikraft, a company synonymous with engineering excellence.
With a workforce of 85+ passionate people, we have made it our mission to provide quality process solutions for the Pharma and the Bio Pharma Industries.
At BioAspire, our team of seasoned process experts, along with our driven and focused Engineers team up to provide solutions that are cost effective, and adhere to the highest international process standards.
Staring with the understanding of your requirement, our team of highly trained designers in conjunction with Process and Engineers and programmers, create a blueprint for the solution we aim to implement.
Knowing how critical the solution is to your Industry and business, we art BioAspire are committed to on time delivery.
For us at BioAspire, we can design and implement solutions ranging from 250 ml to as much as 70 Kl and more.
For us BioAspireans, “to server life” is our ultimate motto.
Complete customized solutions
We at BioAspire know the importance of customization of any process solutions, it offers lots of flexibility to the client in terms of utilizing the foot print in any classified environment, ease operations, simultaneity of multiple operations at a time. Selection of component by choice will make the system as per desire of clients.
Team of process people in design
We believe, A well-designed process solution plays a very significant role in defining efficient functioning of a manufacturing facility and has a major impact on productivity, quality & profitability of the plant.
It is quintessential to understand the process know-how and also to ensure the design meets the necessary regulatory requirements. Our strength is a team of experts coming from real process background, who have handled the processes, products of broad range at different scales for different regulations; we bring very rich experience of process design, scale up, GMP, auditor’s expectations to the table and seamlessly incorporating the same in our design of Process solutions. we carry the experience of designing very critical Process solutions for Biopharma as well as very key sterile pharma clients
Design As Per ASME/GMP/ GDP
In today’s world of Quality, international guidelines become a guiding pole star. They give the prospective for why and how? They define the pathway towards meeting quality criteria as per international regulatory authorities. With our hands-on experience of quality environment, we at BAPS focus on the design in line withASME, BPE, PED guidance for engineering, welding, slopes, dead legs, cleanability and ability to qualify for sterilization (CIP & SIP) and documentation as per GDP.
Plug n play concept
We believe that any process solution should get introduced in any clean room in very short time consumption for installation & handover.
We have enough experience about the qualification & validation activities and their interlink in any GMP facilities. Any system/skid getting erected on site and the time taken by the activities has direct impact on the validation master plan for facilities, HVAC, utility validations, autoclave validations etc. As an end user always expected that the system should get installed immediately & the team mobilization should happen in quick time period.
Hence process solutions designed at BAPS are with unique concept of plug & play. Fully assembled, FAT tested systems are packed as it is and shipped to site. On site after execution of check list, the system is positioned at defined location. Removed from packaging, systems are ready for use immediately after hooking to respective utility connections. It takes very short time for installation, there is no erection on site, no welding at site!
It not only saves extremely valuable time in any project life cycle but also ensures the quality untouched. Ultimately faster, smoother SAT & qualification activities.
QRM based design
ANALYSIS OF RISK FOR THE DESIGN AND THE MEAUSURE OF MITEGATION
APPROACH @ BAPS FOR RISK MITEGATION
In any GMP processes, as per ICH guidance the implementation of QRM is expected at the manufacturing process/products.
Team BAPS believe that the process equipments are the most important part of manufacturing process for any pharma /Bio-Pharma products; hence the process solution/equipment play a key role in achieving the quality of the product directly/indirectly. Success & failure of any process batch is mostly depending on the training/skill set of man power & performance of process equipments/instruments etc.
Team BAPS has a very strong conviction that sooner or later same QRM approach will be made mandatory by regulations at equipment design also. Hence it is an imperative to have an appropriate & proactive integrated approach to meet requirements more efficiently & effectively by incorporating the knowledge & experience into design of all the process solutions.
The risk identified, analyzed & appropriately taken care at process systems design will play a vital role in any QRM.
Anything which has the potential harm to process, process systems, product quality, patients & ultimately the business is “RISK”
Process understanding is the key to identify the potential risks. It is an opportunity to use structured process thinking.
Hence, at BAPS, every single design goes though the Risk assessment so as to get the risk mitigation done at design stage itself to achieve part of QbD- Quality by design at process solutions/equipments.
How it is done at BAPS?
We ask 4 important questions while designing a process system for sterile pharma & Bio-Pharma application.
What is QMS?
- A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. (i.e. areas that can impact the organization’s ability to meet customer requirements.)
- A QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. A Process Based QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance.
Ultimate aim is to have customer satisfaction
HOW: Documented QMS
We at BAPS believe that each & every operations must be done in defined way with a system driven approach & not personnel driven. At BAPS every unit operation is SOP driven so as to get the uniformity & consistency in quality in whatever we design & execute.
Standard operating procedures (SOP) for:
- · Vendor approval
- · RM selection
- · RM approval/rejection
- · Design, proposal, GA,3D, BOQ/BOM, Documentation Manufacturing – fabrication, welding, orbital welding, skid assembling, piping, electro polishing, Inspections, calibrations, buffing, testing, packing, dispatch, handover, Customer complaint, SHE etc.
Responsibility & accountability of project execution in defined manner.
Quality Management Process Model
WHAT IS QUALIFICATION?
It is the tests performed to “Establish confidence that process equipment & ancillary systems are capable of consistently operating within established limits & tolerances”
The Design Qualification (DQ) :
It is part of the Qualification/verification activity. This document ensures that the designed process solution/equipment meets all the specified requirements; i.e. functional operational and safety requirements of the process & end user. It ensures that the design would be in line with the required standards / guidelines.
It is pre-defined, agreed & approved specifications required for equipment to be manufactured.
The Design Qualification shall prove that the equipment is in accordance with the approved Technical Offer and the URS
The DQ shall be executed and completed before the process solution / equipment is taken for manufacturing activity. It should be performed & approved prior to purchase of components/RM.
DQ is the detailed descriptive document for the components, process sequences which the system is capable of executing for respective process.
Should approved by Customer/user.
SOFTWARE DEVELOPMENT TESTING / BENCH TEST
BAPS has in house capability of designing the Process logics / control philosophies for every process solutions designed. In-house strength in converting the logic to smart programming, this testing is performed during the development of the software / automation programs, the screen formats, password matrix, interlocks & all critical alarms that will be loaded onto the process solutions.
The objective is to qualify/verify that the performance of the control system software meets the approved functional specification and end user requirements.
PRE-FACTORY ACCEPTANCE TEST (PRE-FAT):
Once the system is ready as per Approved DQ, at BAPS it is tested for all mechanical, functional, process performance as per the requirements of user , process and regulatory guidance. If any deviation or noncompliance is observed, it will get documented. The system is again checked after taking corrective actions. We believe that the process solution is ready to get commissioned for intended application before it gets introduced to client for FAT.
An approved pre-FAT protocols covering extensive tests are being used for pre-FAT execution. The set of documents are ready for inspection *if required, by client. A through Pre FAT gives lots of confidence to face any authority or client. It is the proactive step taken as a part of our QMS.
BAPS has a dedicated team for pre-FAT & FAT under the function Quality.
FACTORY ACCEPTANCE TEST (FAT):
It becomes an imperative to check, verify the system designed as per requirements of user, process & regulations before it gets dispatched. It is not always practically possible to do all the testing at site; hence FAT becomes a MUST.
Knowing the expectations from client , BPAS has designed a fully equipped dedicated facility for FAT. To provide WET FAT, BAPS has created a state of art FAT center with treated RO & pathogen free, low conductivity water system, complete back up of filtered steam, cooling water, uninterrupted dry oil free air supply with redundancy. All the master calibrated instruments required for the different tests are available with their respective documentation. The FAT facility is designed like any clean room with docking stations, where multiple systems can be tested independently at a time.
FAT is performed at BAPS FAT center, NASHIK. It is performed in presence of end user/client. Its objective is to demonstration to the user that the equipment / system complies with his URS & approved DQ.
We understand the requirements of client & their QA quality function, in line with the same, a detailed FAT protocol is designed at BAPS. It is shared with the client minimum 2 weeks prior to actual scheduled FAT. Any specific test, process requirements can be incorporated in FAT protocol before actual FAT. An approved FAT protocol is used for execution of FAT.
Client have the flexibility to select representative tests & rest can be verified from the approved pre-FAT documents. However, the user is free to ask complete FAT tests.
SITE ACCEPTANCE TEST (SAT):
After a successful FAT, the systems are paked & dispatched to the site. BAPS team of project management does the Installation & commissioning as per their respective SOPs/ protocols. SAT is performed by team BAPS, with our testing instruments, at the user’s site. A pre-approved SAT protocol is used for execution of the SAT. The objective is to verify that the system still complies to URS & DQ , even after transit & change in quality of utilities from FAT to site.
Not all the tests from pre FAT/FAT, but few critical tests like CIP/SIP, pressure hold test, control loop testing etc. are performed after approval from client.
The Installation qualification (IQ) is part of the qualification/verification activity which ensures that every single component on the system is as per required specifications of types, MOC etc. It is the protocol to install the respective system to meet its intended application. It guides how to connect/hook up the system with respective utilities, it guides how to assemble the system. Basically, it is the guideline/protocol to make the system ready for operation.
Operational Qualification (OQ) :
Operational qualification (OQ) is part of the qualification/verification activity which ensures the installed system operates accurately to meet the requirements and expectations of the user/process.
It is performed after approved Installation, it is the protocol to check functionality of the system, it ensures that the said system for its intended application is operating within the said limits/tolerance of the parameters. It ensures that the system is meeting URS & DQ.
Every functional operation is tested in execution of this protocol. OQ ensures & approves that the system is ready for actual intended use.
In any project, timelines for specific activities are having prime importance as it is the chain & interlinked operation in the project life cycle. Any delay noncompliance to the timeline has direct impact on overall project and a real set back to bigger strategic plans too.
We respect the timelines & we deliver it on time. Once the timelines are defined & all the concerned teams are agreed/convinced upon, then for that we are committed. At BAPS, we take all possible strategic decisions to meet the FAT date. The back-end team puts all the efforts in 3 shift operations to meet the commitment.
Any system no matter how beautiful, how accurate it is designed & manufactured, if not delivered on time it really has diluted the goal & importance! We believe in that!
BAPS take pride of that!! We deliver on time!!
Post Installation Service
After last step of qualification SAT is over, the systems are handed over to respective clients. That time onwards post installation service & support becomes very critical/vital.
We respect that the product batch is of highest importance than the system itself. All the efforts, cost & valuable time will go in waste if the prompt, accurate, responsive support is not given. As an end users ourselves, we do understand the importance of the same & hence at BAPS we give highest of the priority to service support & trouble shooting activities. At any given day, our team is reaching client site within 24 hours of the call received. We use all possible ways & means, technology to make client trouble free at the earliest.
We analyze the nature of problem accordingly respective team from engineering, automation, Quality and even process team is taking immediate actions to be with our partner client on site. We have established an open system where no systemic hurdle to delay the actions.