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.
2. 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.
3. 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.
4. 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 :-
a. Building system and Process Support systems.
b. Building utilities (HVAC).
c. Electrical systems.
d. Potable water
e. Steam and condensate systems.
f. Compressed air.
g. Fuel oil.
h. Natural Gas.
i. Control system for Process emissions.
5. Process Support utilities
The Process support utilities that may be requiredinclude:-
c. Process water (Potable, Endotoxin reduced, water for injections).
d. Process solvent.
e. Temperature control fluids-glycol thermic fluids.
6. Process Temperature Control System
Since the reactions to be carried out in Kilo lab and Pilot plant are required to be heated and cooled, Single fluid heating cooling systems can be considered as a part of 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 system etc.
7. Reaction bottom Pan design.
The most important part of any Kilo lab and 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.
8. Isolation Equipment (Filtration and Drying)
Filtration and drying play a significant role in quality and physical properties of isolated API. Filtration and drying operations can have substantial impact on overall plant and throughput and manufacturing cost.
Filtration selection includes compressibility of the solid cake, 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.
Drying equipment used in Kilo lab and Pilot Plant are generally contact dryers (solid in contact with heated surface) and operated in batch mode. Consideration for dryer selection include 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 selection of tray dryers, filter dryers, tumble dryers and rotary cone dryers.
9. 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.
10. 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, @>>firstname.lastname@example.org
1. Kilo Lab and Pilot Plant Manufacturing by Jason C Hamm, Melanie M Miller, Thomas Ramsay, Richard L Schild , Andrew Stewart, Jean W Tom