Our client is an over the counter (OTC) drug manufacturer who make non brand drugs such as paracetamol, ibuprofen, allergy medicine and cold and flu sachets for major UK supermarkets. They also manufacture numerous major recognised branded drugs from other major drug companies.

 

Prior to their IWT Pharma purchase, they were washing everything by hand in their facility, this involved a lot of manual handling and for their operators to be in contact with hot water and harmful detergent chemicals. Washing GMP equipment by hand is susceptible to human error and as a result, their washing processes had been criticised in an audit, which spurred them to switch to automated washing.

 

• 2 x 2Clean Bin and Parts Washer

• 2 x W200 Parts Washer

• 14 x Customised Baskets and Trolleys

• Bulk Detergent Dosing System

• 2 x Warehouse Loading System for loading customised baskets

• Scissor trolley for storage of customised racks

IWT Pharma prides itself on being able to complete complex installations anywhere in the UK and Ireland. Some small challenges that we faced along the way were:

 

• Transportation and movement into place of a single welded chamber is difficult and requires the assistance of a specialist lifting company. It is important that the chamber is handled with care because, by its design, the internal section of the chamber is mirror finished and any damage can affect its functionality.

 

• The customer ordered over 4 customised baskets for the W200 and 10 customised trolleys for the 2Clean to wash over 600 parts from multiple different manufacturing and packaging lines. This required 3D scanning of many of their parts, plus co-ordination for the basket design, requiring their approval and subsequent site delivery. This order of customised baskets and trolleys was considered to be a large order in IWT Pharma terms and we were very proud to subsequently deliver all these items.

 

• Previously washing all items by hand, meant it was a big change for them to move to automated washing. Since the handover of the project, their validation team has worked tirelessly to develop cycles and complete their own validation on the W200’s and 2Clean’s. This has been something we have been able to assist them with, via site visits and remote help.

The installation took place in phases:

 

We delivered both the W200’s and 2Clean’s to site. The W200 is delivered partly assembled and it took around a week to install the two machines on-site. The 2Clean is delivered completely disassembled and so with the help of the lifting company we managed to install both machines in three weeks.

 

After the ceilings and walls had been completed, we returned to site to fit the remote electrical boxes and bulk detergent system and ran both the cables and detergent piping to the machines.

 

Once the machines had been completely assembled and all service connections completed, we commissioned the machines. As part of the commissioning process, we also calibrated all sensors.

 

Working with the customer and following our documentation we successfully completed the SAT/IQ/OQ work with the customer. They were given visibility of the documents before the SAT/IQ/OQ so they could make any amends if required.

 

Our Training Manager completed on-site user training for all operatives of the equipment. This was very well received, and they are now confident to use all the machines.

 

Through our Technical Services Department we offer comprehensive maintenance and breakdown packages on our installed machines. Due to the customer having their own Engineering team, they wished to complete the routine maintenance of the machines themselves, this does not affect warranties in any way so doesn’t present an issue. To assist them in this endeavour we provided a specific on-site Engineer training for them, this covered specifically how to conduct routine maintenance and how to troubleshoot common issues.

With the install of the W200’s, 2Clean’s and the customised baskets, the customer now has a complete automated washing process. The benefits of a fully automated washing solution are:

 

• All bins and parts are washed to the same quality every time, reducing operator error.

• Reduces the use of manual labour and, therefore, ergonomic issues when washing the equipment.

• Provides an audit trail for each cycle as per FDA standards.

• Reduces downtime for the highest value manufacturing and packaging lines.

 

Some manufacturing and packaging lines are of high value to the customer. We worked with them to evaluate how to wash all parts of these lines in a once through configuration, using all four machines, thus reducing downtime further.

 

The customer is currently in the process of developing cycles and full wash bay usage will start once the validation process is complete. So far, the customer has reported that the 2Clean’s have washed their ‘worst cleaning case’ processing bins to a validated standard without the use of detergent. They have also reported that their deduster sets have been cleaned to a validated standard in the W200’s, this was a task that previously took the time of two shifts to complete but can now be completed in a few hours.