IWT: Bringing solutions to meet strategic goals

Having an experience of more than a decade, Mack Universal has set up new benchmarks in the sphere by supplying a wide gamut of pharmaceutical equipment and spares

Mack Universal was founded by Manoj Chaudhari in the year 2012 to serve the Indian pharmaceutical companies with technologies, products and services required for their ultra modern laboratoriess and plant. The company has launched International Washing Technologies (IWT) of Italy, which is world renowned for its state-of-the-art low and high pressure washing equipment and technologies. Techniplast is the parent company of IWT.

IWT has specialised itself in washing, cleaning and drying of production utilities and change parts. IWT has its installations world over in most of the best known pharma companies.

IWT provides solutions that enhance:

• Quality, safety and ergonomic of the workplace
• Conservation of the environment (green approach)
• The outcomes of production

Cost effective, high quality and safe equipment have always been IWT’s first priority.

As a company culture, IWT is constantly looking for solutions to enhance its products to suit client’s business better.

IWT’s high-pressure washing solution for pharma industry

The following issues and points should be taken into consideration:

• The issue of washing
• Washing science
• Technology behind washing systems
• High pressure range of washers
• Main features and ways of use
• Conclusion

The issue

A proven, efficient and validated washing process is capable of eliminating the cross contamination that can be medically significant. Analytical methods, sufficiently sensitive to detect relatively small amounts of APIs, can be the aim for the validation of the cleaning process.

Cleaning: From art to science

Cleaning has evolved over the years from an ‘art’ activity to a ‘scientific’ task.

A new generation of cleaning procedures has begun to emerge. Cleaning processes are no longer an ‘afterthought’ or some aspect that could be developed at a later stage. Efforts were put into the cleaning process to determine what makes a residue difficult to remove and the roles of solubility, mechanical action, flow rates, temperature, contact time and many other fundamental variables.

Wahing science

The removal of the contamination is influenced by several critical factors that must be take into consideration:

• Mechanical action (combined with coverage of the load)
• Temperature
• Chemical action
• Time

All the variables are strictly linked to each other and have a specific relative weight. The key is to find the right balance in order to achieve the expected cleaning results.

Mechanical action

According to the material and the product, it is possible to choose the most effective washing technique:

• Low – pressure washing according to the re-circulation of the washing fluids combined with high flow rate
• High – pressure washing technology which is gradually taking place in the recent years

HP washing principle is based on huge mechanical action generated by water sprayed at over 70 bar pressure through orbital nozzles perfectly covering the surface to clean.

Temperature

Temperature is a fundamental parameter that concurs to achieve outstanding cleaning performances:

• As a general role, although there are some exceptions, the higher the temperature of the washing solution, the higher is the solubility level
• The increase of the solubility leads to a reduction of the washing time which means shorter cycles.
• Water temperature is increased by means of several type of heat exchangers (steam or electrical) and constantly monitored by means of accurate temperature probes PT100 or higher.

Chemical action

Chemicals (commonly known as detergents) are used in cleaning activities:

• Detergents can either be alkaline, acid and/ or neutral
• The use of detergents lowers the cleaning time and water     consumption, but needs to be properly removed in order to avoid any contamination of the load
• Removal is carried out by means of one or more rinse cycles and it is mainly verified by water conductivity monitoring  other analytical methods.

Time

The compounds in use in  pharma production are of different nature, in different forms and with different characteristics:

• Solids, semisolids, gels, ointments and liquids

These can then be divided in:

• soluble in water
• insoluble and/ or hydrophobic

The solubility in water, and therefore the cleaning time, can vary for each type of product. The longer the washing time the longer the exposure of the load to chemical and mechanical action.

The high pressure technology

An innovative range of

• Mobile (M-Line)
• Stationary (S-Line)
• Cabin (C-Line)
• Equipment for washing and drying a wide variety of loads.
• These units are built in compliance with cGMP and
  21CFRpart11.
• The mobile machines can be used as stand alone in production areas (in place process) or in dedicated washing areas.
• The mobile units can also be connected to a washing/drying cabinand/ or to equipment featuring a suitable built-in CIP system.
• The Focus of IWT is to provide automated washing technologies that bring several tangible benefits to the organisation, namely:

1. Minimise the need for the operators to come into contact with APIs and chemicals, thus improve health and safety conditions
2. Eliminate the possibility of cross-contamination between batches
3. Reduce the energy consumption
4. Reduce the water consumption (a precious resource)
5. Reduce the effluent pollution thanks to low use detergent consumption and water
6. Guarantee the repeatability of the results
7. Give evidence (printed batch report) of the cleaning activity.

IWT products

1. M Line

The salient features are

• High pressure mobile washing unit
• Washing pressure from 20 up to 80 bar
• Stainless steel draining pump
• cGMP and FDA compliant
• Two detergent dosing pumps
• Equipped with hydro-kinetic water gun
• Steam or electrical heat exchanger
• PLC + HMI + on board printer.

Drying section

2. S Line High pressure stationarywashing unit:

• Washing pressure from 20 up to 80 bar
• Multiple hydro-kinetic jet guns
• Orbital nozzles to suit specific needs
• Built of AISI 316L stainless steel
• Pharma grade heat exchanger
• Detergent dosing pump
• PLC + HMI
• On board printer

3. C Line:

High Pressure washing and drying cabin:

• Three different sizes: small/ medium/ large
• Washing pressure from to 80 bar
• cGMP and FDA compliant
• Telescopic orbital nozzles
• Self cleaning function
• PLC + HMI
• On board printer
• Drying section

4. IWT also has ‘Column washing and drying unit’ for containers and flexible hoses suitable for:

• Cabins
• Cleaning rooms.

Documentation: Apart from the standard documentation, on request, additional cGMP documentation for the validation work is provided:

• Design qualification
• Installation qualification
• Operational qualification
• Service is also provided, directly from the factory or through
• Our partners worldwide (Mack Universal in India).
  So, to conclude, automatic cleaning procedures are crucial to achieve high hygienic standards in pharma production
• Automatic cleaning allow validatable process and regulatory compliance
• A well planned working method regulated by proper SOPs assures a better cleanliness with a guarantee of no cross contamination
• Flexibility MSC product line allow an unlimited range of washing solutions from a stand alone drum/ bin all the way through very specific and custom sized CPI applications.