BioAspire can contribute to Pharma industry with wide range of process solutions for various process unit operations.
In sterile pharma, the process equipments / solutions has to be designed to have aseptic process operations.
For any pharma aseptic processes, there are multiple unit operations of batch manufacturing/compounding, filtration / holding & aseptic filling. These unit operations are carried out in various process vessels.
BioAspire, has wide range of process solution to cater the need of all process vessels.
Manufacturing / Compounding
- Charging of WFI for manufacturing/compounding and addition of one or multiple ingredients API’s. Volume make up might be required.
- These vessels are needed in various different mixing & temperature controlled provisions.
- When the process is sensitive to oxidation, purging & blanketing with Nitrogen to displace the O2
- From these vessels, the products are transferred to through sterile filtration to holding /filtration vessels.
Holding /Filtration vessels
- These vessels are placed mostly in class-B, A sterile filtered material is stored in these vessel till filling gets completed.
- These vessels may/may not need in various different mixing & temperature controlled provisions
- Sterility of the product is important aspect
- Transfer by Nitrogen or by pumps
- Products may/may not need recirculation depending on the nature of the product.
BioAspire provides all these process solutions with Following features possibilities:
- CIP/SIP able design,
- Mobile /fixed options
- All kind of mixing options-mixers/homogenizers
- Jacketed / non-jacketed
- All options of automation
- With or without load cells or with all other level sensing concepts. (DPT/ Radar etc)
Cleaning In Place- CIP
In any sterile pharma & Bio pharma processing, Process contamination or product contamination can happen from batch to batch of same product, batch to batch of two different products. Removal and cleaning of residues/traces from the completed batches and ensuring that the manufacturing process vessels, auxiliary systems and interconnecting process piping are free from any cross contamination is one of the most critical aspect of any process. Hence effective, consistent, scalable, user friendly, in line with GMP norms and cost-effective design of CIP is very crucial.
With the pharma & Biopharma industry getting matured day by day with constant check by regulatory bodies and the trend of designing multiproduct manufacturing facility requires an articulate approach to ensure cleaning & sterility of the systems.
With our endeavor to help end user with customized options of CIP designing with BAPS’s value added process inputs to suit their process, layouts & budget requirements, we offer all possible CIP solutions to the client. It gives complete flexibility to client to select suitable solution.
- Master /central CIP station and local recirculation
- One tank/two tank system with/without dosing of cleaning agents
- One tank/two tank system with/without heat exchanger
- One tank/two tank system with/without jacket
- Mobile CIP recirculation trolley with /without preparation vessel
- Mobile CIP recirculation trolley with /without HEX
- Mobile CIP recirculation trolley with /without dosing of cleaning agents
- Tankless CIP recirculation Trolley.
- Two tank systems with two pumps for supply & return of CIP
- Two pump systems with independent loops of cleaning agents and local recirculation.
- Mobile One Tank System with Local Recirculation
- Smart design of a combo unit of CIP & SIP in one system skid.
- Complete automated CIP: Most reliable, controlled & consistent performance without any intervention from operator.
- Semi-automated: Reliable, consistent in performance but requires certain level of manual intervention.
- Complete manual option: Not reliable, not consistent as it is directly depending on the skill set of the operator.
One of the biggest strengths at BAPS is the capability to design complete process integration. Our hands-on process handling experience plays key role in making integrated solutions with process transfers, CIP & SIP circuits/loops with complete automation and consideration of aspects of Qualification/validation activities. We can design a complete process block for compounding/holding/filtration till filling machine. Just needs the respective PFD & URS we deliver an entire block rather than giving just stand-alone vessels/skids.