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Peptide Synthesizer from ATR ASAHI!!!!

Peptide Synthesizer

ATR ASAHI has got the opportunity to work with some of the leading Pharma majors of India to cater to their requirements and develop peptide synthesizers (lab and pilot scale) for them. Peptide synthesizers are mostly tailor-made equipment that are required to be designed, drawn, manufactured, tested, and supplied as per the process requirements of the clients.  Initially, the clients may have a very sketchy idea of what they exactly want, which needs to be evolved and firmed up gradually after a series of discussions and back and forth communications. The discussions are basically in terms of how the ordered set up can fulfill all their experimental requirements.

The product manufacture

As mentioned above, something which begins as a rough idea is firmed up after a series of iterations, and the schematic drawing is prepared and agreed with the client to proceed further. Based on the drawing the dimensions of the individual components are frozen along with the material of construction. The major components include the glass reactor, the feed and receiver vessels, the interconnecting piping, the solvent and reagent feed pumps, tubing’s, pneumatic valves, the support structure, as well as the control and automation arrangement. The entire arrangement needs to be supported on a suitable structure besides providing a suitable enclosure. The remote control, monitoring, and operation of the Peptide Synthesiser set up is possible.

Testing and FAT (Factory acceptance test)

The setup testing and its acceptance is an important part of the Peptide synthesizer. The client visits are arranged after the entire set up is ready and installed for client inspection. All the characteristics required and conceived during the design stage are again checked and ticked at the time of FAT. If certain further modifications are required then the same is noted, agreed, and carried out before the equipment is shipped to the client.

Safety

The safety of the entire set up, at the time of testing and inspection and also once installed at the client’s facility is of paramount importance, since the synthesizer may involve use of hazardous flammable solvents and reagents. The entire set up is thus designed and manufactured to be qualified for safe area operation.

Uninstall, drain, pack and despatch

In this leg, the entire set up installed for the client FAT is uninstalled, drained, cleaned by pneumatic air, and packed for despatch.

Erection, installation, testing and product trial (client site)

This is the final stage where the supplied material is erected, installed and product trials are carried (every requirement is a part of the contract) out at the client's site. This ensures that the Peptide assembly meets and fulfills all the requirements and aspirations of the client.

For your requirement of Peptide Synthesiser please contact ATR ASAHI.

 

 




Sodium Hypochlorite (NaOCl) Generation Plants

Sodium Hypochlorite (NaOCl) is a compound that can be effectively used for water purification. It is also used on a large scale for purification, bleaching, odor removal, and water disinfection. With the ongoing Covid-19 pandemic the requirement for NaOCl will go up substantially and hence more such plants will be required and that too very fast. 

ATR ASAHI can supply NaOCl plants with guarantees of up to 10 MT/hour capacities. NaOCl generation involves the use of NaOH powder and chlorine as the main ingredient. The civil works are normally left in the client’s scope. The complete plant machinery includes storage tanks, pumps, heat exchangers, scrubbers, filters, ejectors, interconnecting piping, valves, emergency chlorine evacuation system, etc. The NaOH solid dosing system can either supplied by the client or the supplier.

The plant is also required to be provided with necessary automation and control including control valves, temperature and pressure indicators and controls, flow indicators, pressure, and level gauges and level transmitters, PLC, SCADA, and wiring, and also support structures.

The main arrangement of the entire set up is the chlorine evacuation system to ensure that the operational safety is maintained.

ATR-ASAHI guarantees that all materials and equipment furnished are of first-grade quality and all work has been performed in a skillful and workman like manner in accordance with good engineering practice.

Should any defect due to faulty design, materials or bad workmanship becomes apparent during the guarantee period ATR-ASAHI shall repair or otherwise rectify the defects, free of charge to the purchaser within one week and to purchaser’s satisfaction.

For more information and offer please contact.

Girish Nanoti

gsn@atrasahi.com

P.S.:- Due to the ongoing pandemic, ATR will attempt to make crash/early deliveries.




Buyers Guide to Kilo Lab and Pilot Plants - Curtain Raiser

By- Girish Nanoti

Preamble :-  This blog aims at enlightening the buyer of Kilo lab and Pilot Plant regarding the likely aspects which he or she must consider while making the purchase or preparing the project report for setting up the Kilo Lab and or Pilot Plants. This blog may be considered as a curtain raiser, and if the reader finds the merit then he can request for the detailed guide.

  1. Kilo Lab and Pilot Plant buying rationale

The objective of buying the Kilo lab and or Pilot Plant has to be clear. The Kilo lab and Pilot plant are a part of process development and are a link between lab (trials) and production plant. The objective can be influenced by the purpose for which they are used such as toxicological studies or phase-1 clinical trials or the scale at which they are to be produced. The Kilo labs are also called glass plants. To maintain clear cut distinction buyers may consider Kilo lab as more close to labs and pilot plant as more close to production plants. Whether the pilot plants will double up for production of small batches of API may also be kept in mind.

  1. Kilo lab and Pilot Plant facility design

The basic philosophy behind the Kilo lab and Pilot plant facility design has to be managing a dynamic portfolio of potential products while meeting environmental, health and safety , quality and business requirements. The other consideration can also be the Material of construction (MoC) of the wet part from the point of view of corrosion, clean-ability to avoid the cross contamination. The process conditions like temperature and pressure are also one of the major considerations. Lastly the process automation and data capturing and recording are also important to understand the process and also to meet the statutory requirements.

Air locks may be required to be employed as physical separation of the Kilo lab from the rest of the building. The powder drying and milling may be required to be performed at separate location specifically designed to handle powder and avoid cross contamination.

Down flow booths, fume hoods, barrier technology and other engineering controls may be considered as a part of the containment process.

  1. Unit operations to be carried out in the Kilo lab and Pilot Plant.

It is important to review the unit operations that are intended to be carried out, like reaction work up, isolation, filtration, drying and also the charging and discharging systems.

  1. Utility Systems

The utility systems to be considered for Kilo Lab and Pilot Plant whether as a standalone facility or a extension of the facility are :-

  1. Building system and Process Support systems.
  2. Building utilities (HVAC).
  3. Electrical systems.
  4. Potable water
  5. Steam and condensate systems.
  6. Compressed air.
  7. Fuel oil.
  8. Natural Gas.
  9. Control system for Process emissions.

 

  1. Process Support utilities

The Process support utilities that may be required include:-

  1. Nitrogen.
  2. Hydrogen.
  3. Process water (Potable, Endotoxin reduced, water for injections).
  4. Process solvent.
  5. Temperature control fluids-glycol thermic fluids.

 

  1. Process Temperature Control System

Since the reactions to be carried out in the Kilo lab and Pilot plant are required to be heated and cooled, Single fluid heating cooling systems can be considered as a part of the project package. Single fluid heating cooling systems have evolved over multi-fluid heating cooling systems (e.g. pressurized steam, water, brine). The temperature range required also to be considered. The process control systems also include associated piping, valves, connecting hoses, bypass systems, etc.

  1. Reaction bottom Pan design.

The most important part of any Kilo lab and the Pilot plant is the reaction bottom pan in terms of size, minimum stirrable volume and minimum sensing volume, the contact surface, nozzle orientation, the type of agitators ( with alternate types of agitators to be replaced and used as per the process requirement), etc.

  1. Isolation Equipment (Filtration and Drying)

Filtration and drying play a significant role in the quality and physical properties of isolated API. Filtration and drying operations can have a substantial impact on overall plant and throughput and manufacturing cost.

  1. Filters

Filtration selection includes compressibility of the solid cake, the susceptibility of the solid cake to agglomeration or attrition upon agitation, compound containment requirements and occupational health concerns, the design of the equipment train and development objectives to inform equipment selection for manufacturing commonly used filters include filters, dryers, centrifuge, and Nutsche filters.

  1. Dryers

Drying equipment used in the Kilo lab and Pilot Plant are generally contacted dryers (solid in contact with the heated surface) and operated in batch mode. Consideration for dryer selection includes acceptable drying selection includes acceptable drying time, the impact on powder properties ( i.e. prevention of particle agglomeration or crystallographic form), and the explosibility of the dry powder.

The dryer selection may include a selection of tray dryers, filter dryers, tumble dryers, and rotary cone dryers.

  1. Engineering Control Equipment

Engineering control equipment provides the primary level of protection for the worker from hazard associated with chemical exposure during the process operation. Common type of engineering controls found within the pilot plant and kilo lab are flow hoods, barrier isolation technology, solid transfer technology and sampling technology.

  1. Process automation

Most of the pilot plant facilities have modern process control that provides basic control of primary process parameters, such as temperature and pressure. Less common to pilot plant facilities are the recipe driven process automation systems (recipe control) found in manufacturing, which may have features like advance process controls and business systems interfaces.

For a more comprehensive guide please contact Mr. Girish Nanoti , @>>   gsn@atrasahi.com

References :-

  1. Kilo Lab and Pilot Plant Manufacturing by Jason C Hamm, Melanie M Miller, Thomas Ramsay, Richard L Schild , Andrew Stewart, Jean W Tom

 






Transparent Processes Enabled! Choose Your Glass Wisely.

(Don't get out on the winning ball in the game of cricket.)

You are attending a party and are about to pick the drink of your choice - Champagne, wine, beer, or any other drink. You make a pick and are about to take your first sip. What happens if the Glass suddenly breaks… spilling on you and spoiling your dress, mood and ultimately the evening. Lastly you loose your drink as well.

Bl…dy Hell. And you start thinking alas may be you/your host may have chosen glass wisely.

What happens if your Glass is not holding a small portion of your beverage but a big portion-several litres of your precious chemical? And what if Glass is holding the final product? As your Glass crosses stage after stage with the content from raw to the finish stage, the stakes go even higher and higher!!!!!!!!!. It's like getting out on the winning ball in the game of cricket!!!!!!

Would you like to report the news of Glass breakage to the management????

When you decide the Glass next time be it for the drink or for handling chemicals …. will you be wiser?

The Glass is not merely for toast and taste… it may also be for various industrial purposes like handling highly pure and or highly corrosive media, which can be very challenging some times.

You may like to maintain the highest purity level of your product and avoid contamination at any cost to avoid losing your product batch. Keeping the plant and machinery safe from corrosion can be the other part of the challenge. How do you handle purity and corrosion at a time?? You use Glass.

The industrial glass plants offer high operational reliability and very low maintenance cost. The modular designs of the glass plant provide constructional flexibility to adapt to frequent changes in the plant responding to the process changes.

Just merely having Glass is not enough. We use borosilicate 3.3 Glass straight from the inventor Schott Germany. We provide Glass with the uniform wall thickness to ensure uniform thermal gradient across the wall thus avoiding thermal shocks, the main reason behind the Glass breakages. We provide construction with ball and socket joint which is more leak proof compared to the flat joints. This further helps us to avoid use of bellows, the construction of which results in hold up material at the bellow joints. This carried over hold up material results in the impurity and contamination in the next batch taken in the reactor.

Our all Glass designs are GMP qualified…one of the pharma requirements.

The right process technology with the right glass design with the right manufacturing will ultimately make your product right and it cannot go wrong at the last minute when the stakes are highest.

Hence it is well said… Choose and Use your Glass Wisely.