Cleaning procedures have become more and more important in the pharmaceutical manufacturing environments and they have been recognised as critical steps in the improvement of the final product quality.
IWT’s daily mission is to deliver the finest equipment in one of the highest regulated environment’s existing. Our absolute focus is to achieve regulatory compliance, to accomplish the validation of both systems and processes, to install quality in every engineering phases and to exceed any safety standards.
IWT cleaning systems are developed following worldwide standards and guidelines:
- EU GMP (Annex 11 and 15 above all)
- FDA 21CFR part 11 for software and part 210-211 (GMP)
- ASME – BPE
- ISPE Baseline
- Ph.Eur and USP
IWT products meet the EU requirements (CE marking) as well as UL/CSA standards.
The final goal of any validation is to assure the equipment under testing is not only suitable for the intended purposes but that it is also built according to the user’s requirement specifications - meeting, if not exceeding, guidelines and industry standards.
At IWT we strongly believe that communication with our clients is the key for a successful partnership. Several protocols and documents are shared upfront in order to set clear and definitive project targets, which will constitute the bases for designing and manufacturing phases as well as benchmarks for all the commissioning activities.
Our comprehensive documentation includes:
- QPP Quality project plan
- FDS – HDS – SDS normally provided and commonly agreed
- FAT, SAT IQ/OQ and OQ Alarms
- WPS-WPQR certifications
- RX analysis of the welding
- Calibration SOPs and certificates
- Materials and components traceability matrix
- Change control system whenever required
Once the on-site handover is accomplished, our team of highly skilled technicians will always be available to support any PQ and/or cleaning validation activities you might require as part of your specific quality insurance protocols.
The design of the washing equipment and relevant accessories has an enormous impact on time, efficiency and throughput of the cleaning processes. Proper engineering also influences how easily and ergonomically material can be circulated from production lines and washing areas or for CIP applications how quick and effective the in-place setup will be. In order to minimise the downtime between your production batches, IWT always applies a risk based approach in the evaluation of your needs, layouts and working procedures with the aim to release quality products with a perfect blend of performance, timing and cost.
Years of experience and multiple complex projects managed for multinational companies result in a solid knowledge and understanding of the cleaning dynamics. These are the cornerstones of IWT expertise to deliver different level of custom solutions to match your unique application to process: product contact parts, format parts, tanks, drums and bins, glassware, trays...and many more! All units manufactured feature premium quality components selected from top brands and long term durability.
Mechanical design according to the industry standards and guidelines is then complemented by a user friendly control system that is GAMP5 and 21 CFR Part 11 compliant and by a PLC code based on a Siemens platform.
All the software is developed in house by our team of dedicated engineers to guarantee the full responsibility on analysis and validation of the code itself, this combined with a complete code handover to clients are meant to speed-up and simplify both maintenance and troubleshooting activities.
The human machine interface (HMI) provides a simple gateway for users to build the most suitable cleaning cycle according to the different loads.
Different user access levels (4 available as standard) grant full protection of the systems against unauthorised logins.
An embedded Ethernet connectivity allows integration of the washers with SCADA systems to manage (for example) electronic transfer of the batch reports, setting and troubleshooting from a remote location, as well as date and time synchronisation with the company network.
All IWT systems are designed with safety in mind for both operator and process.
A full risk analysis and consequent HAZOP is part of the early engineering phases to provide equipment capable to deliver safe, repeatable and reliable cleaning results.
Calibrated probes, sensors and specific controls are embedded to guarantee a real time monitoring of critical parameters and accurate process diagnostics.
A safe process ensures not only a clean load exceeding the QA acceptance criteria but also prevents any possible cross contamination between product batches and any microbial growth during inoperative phases.
To do so all the washing machines are designed for full drainability and cleanability of chamber, pumps and piping.
The bio-seal separation and door interlocking system which allows the unload door to be open only when the cycle is duly accomplished, permits a perfect separation between loading and unloading areas when different levels of classification are necessary.
IWT Project Management Team
IWT UK have built a reputation of high quality and consistent project management, this is due to our dedicated Project Management Team who have many years of experience in the Pharma sector.
So, why have a Project Management Team?
There are key benefits to appointing a dedicated IWT Project Manager, these include:
- They are your single point of contact for both client and contractor
- They have a complete overview and control of all project aspects
- IWT Project Managers have a direct route of communication to the manufacturing plant
So what does this mean for you?
- Our projects run on time and cost effectively.
- We implement a proactive approach which saves on resources, effort and cost.
- We can offer better solutions through better planning.
- We will regularly communicate and report to you.
- IWT can reduce future risk before the problems occur.
- We deliver high quality product installations, the first time and on budget!
Here at IWT Pharma UK we have 4 project managers. They use well practiced techniques and ensure communication is at the heart of all we do throughout the key stages of any project. Where required we can quickly embed ourselves into the project team (Clients, Architects, Planners, Engineers, Contractors), to successfully deliver your project.
We can offer you a wide range of services all free of charge:
- Lay outing, 3D modeling and rendering (Autocad and Revit)
- Throughput, workflow and workload analysis
- Return on investment consultancy
- GANTT charts integration and project time management
- On-site surveys and coordination meetings
- Validation processes (IQ, OQ, PQ, Microbiological services, FAT, SAT)
- Multiple level training* (operators, managers, maintenance)
Don’t take our word for it, here is what some of our clients say about working with our project management team:
“...The project management was excellent!”
“…the trainers, engineers and project manager were extremely professional”
“The project management was very good”
“I found the communication from the Project Manager to be excellent”
“I was impressed with the professionalism of IWT as a company”
We can provide you with the ultimate service solution…
Who could possibly be better placed to look after your specialist equipment than the manufacturers? Here are just a few of the reasons why a IWT Service Contract makes such perfect sense:
IWT Pharma Engineers for IWT Equipment: Factory-trained and approved Engineers who know your equipment inside out.
- Strength in Numbers: Our large service team boasts over 125 years collective experience of working with IWT & Tecniplast products and allows us to respond quickly and efficiently when you need us most.
- Generic Just Won’t Do: Our single-minded focus on our own product range allows us to specialise in everything we do. Therefore our test protocols, calibration tools and spare parts are all specifically designed to guarantee your machines performance.
- Ready for Today whilst Preparing for Tomorrow: With over 20 nationwide Engineers, this allows us to respond quickly and efficiently today whilst our proven Apprentice Engineer programme is successfully ensuring we are ready to support your future needs.
- Safe & Secure: All our Engineers are direct employees, undergo strict security vetting and are fully educated… so all aspects of your sites security are in safe hands with us.
- Flexible Solutions: Our competitive range of service contracts allows you to choose a level of cover that best suits your site; balancing support needs with budgets!
Here for you whenever, wherever you need us…
We’re here to help with all after-sales and IWT product support needs including:
- Flexible Range of Preventative Maintenance Contracts
- Emergency Breakdown Support
- Certified Spare Parts & Consumables Supply, DOP Testing
- Installation, Commissioning, Validation, Manuals & Documentation
- Training & Support Packages
- Relocation and Re-commissioning Packages, Refurbishment and Re-conditioning Packages, Extended Warranty Packages
For further information please contact the IWT & Tecniplast Service Department on 0345 833 9822 or email firstname.lastname@example.org