Steps to plan and setup for High Quality Active Pharmaceutical Ingredients Unit
Are you planning to set API Unit?
Are you willing to setup/scaleup your R&D Unit?
Are you willing to find ROI for your planned Unit?
Are you willing to determine Yield for your API Unit?
Are you willing to make your API contamination free?
Are you willing to discover Reaction Rate for your API Unit?
Are you facing quality challenges in pharmaceutical compounds?
Are you willing to ensure/improve quality of your Active Pharmaceutical Ingredients?
Then this is for you
Most of the time, the Scientists and Management stands contradictory, which results hurdle in growth. Here’s our small effort to bridge the gap.
A common saying, prevention is better than cure, many companies can avoid the unexpected turn around. This can be achieved through:
- Documentation and
- Testing ⇌ Scaling.
It is advisable to perform Research on Laboratory scale, discover the effective way, document the process and test on small scale/pilot plant prior to setup full fledge production unit. This helps overcoming significant issues arising on large-scale production unit.
Most often, some organizations and sponsors oversight the importance of things such as Laboratory Scale Reactors, R&D unit, etc. and tend to avoid equipment made from Borosilicate 3.3 glass considering them risky and time wasting. Here’s the importance.
Importance of Borosilicate 3.3
Glass Borosilicate 3.3 glass, popularly called scientific glass is made from Silica and Boron with few other additives. This glass has few characteristics such as Transparency, Contamination Free, Non-Corrosive, Non-Reactive, Non-Inheritance, Thermal shock capabilities up to 80⁰C, etc. Borosilicate 3.3 glass has softening point at above 700⁰C and therefore can be used easily as per suitable temperature of sealing material such as PTFE, Viton, Silicon, Kalrez®, PEEK, etc. For the reactions under high temperature, reaction temperature may be brought down by reaction under Vacuum.
The transparency provides visual appearance of reaction which helps in documentation during research and discovery. Borosilicate 3.3 glass stands non-reactive to almost all chemicals except Fluoric acid (HF), Phosphoric acid (H3PO4) and strong hot caustic solutions and thus most preferred MOC among scientists & chemists. The non-corrosiveness makes the equipments easy to clean for next research & discovery. The non-inheritance property does not alter the reactions by effect of material, color, smell and taste.
Glass shall not be used as it is fragile and dangerous to use.
Fragileness of glass can be zeroed by handling care and eliminating physical impact. Glass is extremely suitable for vacuumed application and better thickness may be requested for pressure applications. High Pressure Glass Reactors is the right answer for such applications.
Research, Discovery & Documentation | Laboratory Glass Reactor
The first step begins with research in laboratory. The Jacketed/Vacuum jacketed Lab Glass Reactor in the range of 250 mL to 5000 mL is an excellent choice to begin with. It provides a reliable reaction station to view analyze and discover the reaction.
An advance training and standardization phases of API development, when you're seeing exactly how the chemistry will function, is a fantastic illustration of this. When it comes to developing/ identifying a manufacturing process. Vacuum Jacketed Glass Reactors help the research & discovery in cryogenic reactions. The range may be used for scaling and document for pilot scale unit.
Testing & Documentation | Advance Glass Reactor System
The main benefit of deploying an advance Glass Reactor system is that it allows having a better sense of how a process will perform in production on a much smaller scale (usually up to 100 liters). It is critical to identify potential problems in the plant to avoid squandering huge amounts of raw materials and other expensive resources. Furthermore, getting it corrected before going into production might result in a quicker time-to-market with fewer costly delays.
At API manufacturing businesses, it is advised to use advance Glass Reactor system, which are little expensive, but worth investment, in terms of quality and consistency. Earlier, when scientists used round-bottom vessels, they came into some unpleasant surprises, when they first evaluated a method in a pilot Glass Reactor in a research lab. They had to go back in research, development and documentation phase, recalling procedure several times.
With the use of advance Glass Reactor system, problems may be identified and corrected prior to planning & deploying main manufacturing facility.
Safety in Jacketed Glass Reactor (Double Wall)
Benefit of using a Jacketed Glass Reactors is its safety.
- Chemicals & Solvents are separated from a Jacketed Glass Reactor via a valve in the vessel's bottom because a glass vessel is usually emptied by picking it up. Picking up a vessel can be hazardous, and if you heat one with a traditional mantle and the reaction becomes out of control, there is no way to cool it.
- Users get clear inside view, it can be made sure that, no other undesired residue is present in Glass Reactor prior to adding the ingredients, as it may lead to inappropriate reaction and false documentation.
- The ongoing reactions may be documents with the visual change of appearance.
- The user may document the Yield & Reaction rate. The user may document consumption rate of ingredients.
- Jacketed Glass Reactors prevents localized heating which may affect the desired reaction.
- User can ensure that, the residue left post reaction is successfully drained through Zero Hold Flush Bottom Valve.
- User has added advantage to keeping an eye of using Clean in Place system. User can ensure the cleanliness of Glass Reactor after use.
- Glass Reactors are equipped with pressure safety valve, which ensure release of excessive pressure, preventing accidents.
- Rupture disk may be deployed additionally to prevent accidents from pressurized reactors.
Advantages of Vacuum Jacketed Glass Reactor (Triple Wall)
Adhering to safety benefit of Jacketed Glass Reactors, below are few advantages of using Vacuum Jacketed Glass Reactor.
- Vacuum Jacketed Glass Reactor enables the user to document cryogenic reactions.Vacuum jacketed Glass Reactors do not allow frosting on walls providing clear view to reactions.
- Vacuum Jacketed Glass Reactors prevents hot & cold burns user may accidently have by touching the Glass Reactor outer wall.
- Energy saving. Lowest impact of ambident temperature and thermal loss.
Safety for Scientists & Chemists | Laboratory Gas Scrubber
One shall never forget the risk involved in research. These risks may be in relation to reaction station and discharge from it. Risk involving the reaction station have been addressed above, however, the risks involved from discharge may be more obvious as in many cases, they remain unconsidered and unidentified. Ideally, the Lab units are used in closed Laboratory under fume hoods. Still, one shall not rule out the possible risk for environment and users. It is advised to neutralize and absorb discharged gas(es) from the reaction station and hence Laboratory Gas Scrubber shall be used.
Laboratory Gas Scrubber is a small unit, in which discharged gas is pumped in to react with neutralizing agent. Gas(es) will be dissolved (mixed) in liquid and then may be discharged as per norms. The use of Gas Scrubber is also useful to calculate the monetary effect for effluent that may be generated in final production unit. The entire unit of Laboratory Gas Scrubber is skid mounted and may be ported to desire location as per requirement.
Advantages with Ablaze Export
- Dedicated team of Engineers and Executives.
- Requirement Analysis & Designing to provide complete solution.
- Committed for uncompromised quality.
- Ensure and committed for Customer’s Happiness.
- Unmatched after sales service support and assistance.
- Documentation set like GAD, Certificates & Detailed Installation & Operation Manual.
- Provides 3D Modeling for better understanding.
- Test support like Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
- Documentation like Design, Installation and Operation Qualification (DQ, IQ & OQ).
- Respect for Privacy. Project Details not shared as per NDA.
- Manufactured from European glass raw material.
- Equipments manufactured as per Suggested drawing & requirement.
- Choice of Metallic MOC like Stainless Steel Grade 304, 316 & 316L and Hastelloy C-22 & C-276.
- Manifold system for preventing accidental damages from utility connection.
- DCS & SCADA available on request.
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