Multiple Effect Stills
The Neelam multiple effect stills consist of a series of pressure vessels in the form of columns, called distillation columns or effects, that are interconnected, communicating vessels. Each column is divided into two parts: a double tube sheet (DTS) heat exchanger that acts as an evaporator, and an upper chamber used to separate pyrogens preventing the drops carrying impurities from reaching the end of the column. Multi Column Distillation Plant is supplied as a compact unit on a skid with all components readily accessible.
- Inlet water conductivity monitoring
- Point to obtain pure steam from the first column
- Condenser for higher WFI
- Hot stand-by mode
- Sanitization/Sterilization of the different columns and WFI condensers Protection panels
Neelam Industries Multiple Effect Water for Injection Stills are FINN AQUA based designed and constructed to produce pyrogen-free sterile water (WFI) in full compliance with cGMP guidelines as per FDA and EMEA requirements.
Engineering and Manufacturing practices follow ISO 9001 procedures, ASME BPE criteria, GAMP guidelines, etc. Design and construction meets the most stringent Regulations and Codes from Europe, USA and others concerning safety and pressure vessels.
To ensure the equipment meets your requirements, we work in partnership with you and a dedicated team follows your order as a unique project. We develop specific Quality Plans (DQ, IQ and OQ) and undertake factory acceptance testing (FAT) to give assurance, performance and quality.
The design of the unit offers excellent performance for production of water for injection. Simplicity and efficiency: A group of distillation columns in series designed to evaporate the purified water and condense pure steam. Their design allows the steam water drops, containing impurities, particles and pyrogens to be separated by the effect of gravity. This design has proven to reduce the level of endotoxins by 3 to 4 log.
The unit and all its components such as feed water pump, pre-heater and condensers are mounted on a stainless steel AISI 304 skid.
All parts in contact with the media are made of stainless steel AISI 316L, insulated with mineral wool (asbestos-free material) with external cladding made of stainless steel AISI 304.
Inner surfaces are polished to Ra < 0.64 µm and electro polishing is an available option.
Hygienic design: Including clamp connections, orbital welding techniques for tubing and components, minimisation of dead legs and proper piping slopes for self-drainability, double tube sheet construction in first column, condenser and pre-heaters, diaphragm valves for distillate/reject, etc
All welding is carried out in inert gas atmospheres (argon), with automatic orbital welding whenever possible.
Sampling of WFI: the generated WFI can be provided with a collection mechanism for detailed chemical analysis.
Online printing of relevant parameters of the process is provided for process documentation.
Generated WFI meeting the below specified standards microbiological standard
- endotoxins < o.25 eu/ml
- toc < 500 ppb
- microbial limit
- physio chemical standard
- carbon dioxide
- heavy metals
- total solids
- ph =5-7
- conductivity at still outlet
In compliance with :
cGMP, GAMP, ISO 9001 : 2008