Pyrogen free water for the manufacture of vital pharmaceutical ingredients

Pyrogen free water for the manufacture of vital pharmaceutical ingredients

CASE STUDY : ALBUMEDIX LTD

Pyrogen free water for the manufacture of vital pharmaceutical ingredients

Project: Commercial Albumin Production Plant Capacity Expansion
Client: Albumedix Limited
Main Contractor: Scitech UK
Duration: May 2019 – November 2020

Puretech designed, manufactured, installed and commissioned a fully validated system for the generation and distribution of essential pyrogen free water to replace the existing legacy system at Albumedix’s facility in Nottingham, UK.

 

The Client
Albumedix Limited is a UK based large-scale cGMP manufacturer of pharmaceutical ingredients and the only provider of USP-NF compliant Recombinant Human Albumin. Its products are vital to the manufacture and supply of pharmaceuticals, vaccines, diagnostics and medical devices globally.
In addition to being a producer of pharmaceutical ingredients in its own right, Albumedix is a single source of supply for many global producers and distributors of medicines, in almost all cases, where there is no viable or interchangeable substitute.

Background
The manufacture of Recombinant Human Albumin is a batch process. Due to increasing demand, Albumedix needed to increase their production capacity by reducing the batch manufacturing time. A major bottleneck to this ambition was the capacity of the Pure Water system, so a new water generation, storage and distribution system was required. To cope with the increased demand, the new system also needed to be capable of running continuously to minimise any downtime for maintenance.

Delivering a pyrogen free water system
The system Puretech designed and supplied comprises a 12,000-litre break tank, pre-treatment skid, including duplex softeners and Granular Activated Carbon Filters, two Genesys (RO/CEDI/UF) generation units, each capable of producing Water for Injection at a rate of 7,500 litres an hour, installed in parallel to provide continuity of supply, and a 15 m3 stainless steel storage tank with distribution skid. The distribution skid feeds two loops which serve the manufacturing facility, each loop operating at up to 45,000 litres/hr to supply the manufacturing process. The systems are sanitised using automatic Hot Water sanitisation sequences.

To conserve waste water from the generation system, an Oasys RO recovery system was included to increase the permeate conversion rate from the standard 75% at full capacity to nearly 92%, the water saved is recovered and returned to the raw water tank for re-use in the generation process.

Puretech received the order in May 2019 and carried out the FAT (factory acceptance test) at the company’s engineering facility in Redhill, UK in December 2019. Commissioning was due in April 2020 but due to COVID-19, this was delayed to August 2020. Hand over and (socially distanced) training was completed in November 2020.

SCADA Integration
Albumedix wanted the distribution system to be controlled via their site SCADA system, so Puretech worked in conjunction with site control contractor, ASTEC Computing , supplying control panel hardware and producing the functional design specifications, for them to write the necessary software for the integration, and working as a team to commission and qualify the system together. The generation and pre-treatment system controls were produced by Puretech and these were networked to the Albumedix Data Historian package for archiving of system data.

Raw Water to point of use solution and unparalleled customer service
The delivery of the new Albumedix system, overseen by Scitech as the main contractor, was originally tendered as three packages: Generation, Storage & distribution skid and Installation of the distribution loops. Puretech is one of the only companies worldwide that has ‘in house’ capabilities to deliver all three packages, providing Albumedix with a single specialist supplier for raw water to point of use. Puretech’s successful delivery on previous projects working alongside Scitech and the ability to deliver the whole project were both contributory factors in winning the contract but so too was Albumedix’s first-hand experience of the Puretech team’s service capabilities and willingness to work collaboratively to help find effective solutions.

We are proud to have provided a large scale, effective, integrated system for producing pyrogen free water for Albumedix, which will help them to increase the positive impact their work has on the lives of millions of people throughout the world.

Delivering in record time for coronavirus wards at Epsom University Hospital

Delivering in record time for coronavirus wards at Epsom University Hospital

Delivering in record time for coronavirus wards at Epsom University Hospital

Epsom Hospital workers on site

Project: Epsom University Hospitals Covid-19 Wards

Client: Interserve / Epsom and St Helier University Hospitals

Timing: 25th – 28th March 2020

Value: £1.6M

Medical Gases completed a project, including over 1000 meters of pipework, in less than a week to boost oxygen supplies to the coronavirus wards at Epsom University Hospital.

 

Background

In early March 2020 Medical Gases was contacted by Interserve for a project to increase the supply of oxygen to two maternity wards at Epsom University Hospital, which were being converted to provide accommodation for coronavirus patients during the pandemic.

 

The challenge

Supplying the required oxygen to the wards necessitated running 54mm oxygen main pipework from the existing main through the occupied hospital, including installing pipework along the ambulance corridor being used to admit coronavirus patients.

Epsom Hospital workers on site

Working through the night to deliver a solution

To save disruption to hospital staff and patient traffic, Medical Gases carried out the installation at night. A team of 15 people worked from 5pm to 5am on three consecutive nights to complete the run of 1000 metres of pipework. The contract, which would ordinarily take around a month in an occupied hospital, took less than a week from instruction to commissioning. The speed and quality of the installation is wholly attributable to the skill, knowledge and commitment of the Medical Gases team, who draw on the experience gained from the company’s 37 years’ experience of delivering this type of contract.

Throughout the work, to protect themselves and others, the Medical Gases team had to wear full PPE, disinfect their tools daily, go through a post work regime of showering and washing their work clothes and at the end of the contract they had to isolate for a week.

This completion of the Epsom Hospital contract in record time is an achievement to be proud of. The team worked long hours under very challenging conditions, and at potential risk to their own health, to ensure that coronavirus wards were up and running as quickly as possible, knowing that without oxygen the facilities could not function. We are very proud of them and grateful to their families for their support.

 

Following the successful completion of the Epsom Hospital system, Medical Gases carried out  projects to provide oxygen for covid-19 provisions at the Dragon’s Heart Hospital at the Principality Stadium and the Royal London Hospital. We are immensely proud of all our staff, who have worked so hard to deliver, and showed their commitment in such challenging circumstances, and are grateful to the suppliers who went above and beyond to support them. Thank you all.

Providing critical oxygen delivery system to Dragon’s Heart Hospital

Providing critical oxygen delivery system to Dragon’s Heart Hospital

Providing critical oxygen delivery system to Dragon’s Heart Hospital

Dragon Heart COVID ward under construction

Project: Dragon’s Heart Hospital Principality Stadium

Client: N G Bailey / Cardiff & Vale University Health Board

Timing: April 2020

Value: £1.6M

 

Without oxygen the Dragon’s Heart Hospital, conceived as a response to the coronavirus pandemic, could not function. Demonstrating outstanding commitment, the Medical Gases’ team designed, delivered and installed a system serving 1586 beds at the Dragon’s Heart Hospital in the Principality Stadium in just four weeks.

 

Background

In light of the evolving COVID-19 pandemic, and the rising number of confirmed cases testing positive for Covid-19, Cardiff and Vale University Health Board identified that additional bed space would be needed to accommodate patients in the area.

The Principality Stadium was identified as a suitable venue to accommodate the anticipated increase in demand, and Ysbyty Calon y Ddraig – the Dragon’s Heart Hospital was conceived.

It took Medical Gases just three weeks (9th – 30th April) to install the oxygen terminals essential to the scheme, leaving a week free for commissioning to successfully deliver the project by the 7th May deadline.

 

The Challenge

The main challenge in delivering oxygen to terminals for the planned 2000 headspaces at the Dragon’s Heart Hospital was time. The hospital needed to be operational within weeks rather than months. Typically, a project of this scales takes two to three years to deliver, Dragon’s Heart had to be delivered in four weeks, from Medical Gases receiving the order to the system being operational. Working within the guidance and restrictions imposed as a response to Covid-19 added an additional complication to a challenging timetable and this was compounded by the Managing Director (On site project managing) contracting Covid-19 in the second week of the contract, followed by the company’s Technical Director, a commissioning engineer, senior project engineer and several members of the workshop team.

 

The Solution

 

  • Planning

Medical Gases did a considerable amount of organising so that on Thursday 20th February, when the order was received, the team were able to divert resources, including labour, plant, equipment and materials, from other projects immediately.

 

  • Manpower – mobilised and prepared

Medical Gases’ forward planning meant that 40 members of the team were immediately on the project. To complete the project Medical Gases’ labour manager arranged over 50 operatives on site. A further five project managers, four supervisors, two directors, a labour manager, a logistics manager and a support team of people in the office, in the factory and making deliveries were involved.

The logistics involved in achieving this included ensuring those on site had to be put through the necessary induction sessions, provided with access passes and PPE, found accommodation etc. All this was achieved in just three weeks.

To ensure as few delays as possible in getting the people and resources required on site, everyone involved in the project was issued with a document to present to police etc. as required, identifying them as carrying out essential work.

 

  • Working together

The delivery of Dragon’s Heart Hospital highlighted the value of the excellent working relationships Medical Gases has worked hard to build and maintain during its Thirty Severn years in the business:

Predictably, securing the necessary supplies during the Covid-19 shutdown was challenging and Medical Gases’ relationships with suppliers were paramount. Medical equipment manufacturer Precision UK in Stockport, whilst working under extreme pressure supplying the majority of the coronavirus emergency hospitals, still managed to manufacture the necessary medical equipment and provide the pipework, without which Medical Gases would not have been able to complete the project.

In the same way that Medical Gases has invested in building relations with suppliers, it has worked hard at developing its relations and reputation with the companies it works for. Which is how main contractor, N G Bailey approached Medical Gases for Dragon’s Heart.

Appreciating the need to properly look after those working on site delivering the contract, N G Bailey organised the re-opening of hotels to accommodate workers, arranging a room only service to stay within the shutdown guidance. They also arranged a free of charge temporary kitchen and dining room open from 7am to 2am on site, providing food and drink for workers 19 hours per day.

Dragon Heart COVID ward under construction
Dragon Heart COVID ward under construction

Knowledge and commitment

Few, if any, other companies could have achieved what Medical Gases has at the Principality Stadium. Being able to mobilise such a knowledgeable, committed team in such a short time is only possible when you have the longevity and scale inspire the loyalty that Medical Gases does. The company has worked hard over the last Thirty Severn plus business, developing relationships and knowledge, which means it can respond quickly and effectively when a challenge such as this presents itself.

Both onsite and offsite, the Medical Gases team pulled together to ensure the success of the project.

 For those on site, working under extreme pressure in terms of timing meant working fast and working long hours whilst maintaining Medical Gases standard of workmanship. One worker covered 47 000 steps in his shift, like most running around the site to get the job done. 12- 14 hour shifts meant staying away from home for three to four weeks continually, living in a hotel room where, for the safety of the hotel staff, there was no cleaning or room services.

“The commitment of the staff was a key factor. Everyone worked seven days a week. Everyone went the extra mile, whether that meant jumping in the car to deliver a part to Wales or anything else. I am so proud of my team and grateful to them. What they have achieved is incredible.”

Andrew Barrett, Managing Director

 

Maintaining Purity

Medical Gases is justly proud of delivering the Dragon’s Heart Hospital on schedule but as important as meeting the timing is ensuring the quality of the delivery. The project had to be signed off by the NHS Trust’s pharmacist, without which the facility is not fit for use, so all quality standards had to meet the pharmacist’s requirements. The project was signed off with no issues and exactly on time.

 

Medical Gases delivered this significant project at a speed not previously thought possible, and with no compromise on quality. It is a testament to all those involved. The Dragon’s Heart Hospital contract ran concurrently with a project to provide oxygen to the Royal London Hospital. We are immensely proud of all our staff, who have worked so hard to deliver, and showed their commitment in such challenging circumstances, and are grateful to the suppliers who went above and beyond to support them. Thank you all.