Pharma/Biologics – Commissioning/ O&M

Project Description:
This Biopharmaceutical client has a substantial portfolio of approved and investigational biologic medicines across multiple therapeutic areas, including Oncology, Virology and Immuno Science.

Integration is the immediate goal when a LotusWorks team arrives at a new client site. There is always a steep learning curve for any team- new facilities require new procedures, job plans and safety documentation, all of which must be created. This site was the same.

Given a very ambitious and tight timeline, LotusWorks completed Commissioning work ahead of the mechanical completion dates, Commissioning work ahead of the mechanical completion dates, in turn assisting the qualification teams when the systems were ready to validate.

While there was a steep learning curve while carrying out commissioning, this site familiarisation stage meant that the LotusWorks team found they could hit the ground running immediately in their Operations & Maintenance role and very quickly became an integral part of the client site.

Project Services:

• Worked alongside the system vendors during commissioning for all utility, manufacturing, life safety and waste systems
• Construction, maintenance and testing of existing systems ready for commissioning.
• Operations and maintenance of the black utility systems including;
  – Steam boilers generation and distribution.
  – Softened water system
  – Process and HVAC chillers
  – Cooling Tower
  – Compressors and air dryers
  – HVAC systems
  – CRAC Units
  – Fuel oil supply and distribution
  – Low temperature hot water and domestic hot water skids
• Writing and reviewing job plans, risk assessments, method statements, SOP’s and other technical documentation
• Maintenance of electrical systems including, UPS, generators, distribution, switching, emergency lighting and earthing, along with alarm monitoring; fire alarm system, fire water system and gas supply, monitoring and distribution
• Other maintenance responsibilities include: Bio-inactivation, chemical dosing and pallet washer skids, alongside white noise, DI water, chemical testing of water systems and chemical free steam systems and waste water treatment plant.

Outcomes:

• LotusWorks tailored the commissioning process to the individual needs of this client – Verifying and documenting, that the facility and all its systems and assemblies are planned, designed, installed, tested, operated and maintained to meet client needs reducing any faults or incidents throughout the facility lifecycle.
• LotusWorks quickly identify unnecessary and unproductive maintenance work and alter the reactive, preventative, predictive and proactive maintenance plan accordingly to create significant cost reductions and increased facility efficiencies
• The client experiences comprehensive data capture on the integrated systems, ensuring traceability and managing equipment lifecycles
• LotusWorks minimize shutdown time and costs, without compromising on safety and quality which, increases capital assets performance
• Complying to environmental and health & safety standards, the client experiences production safety and product quality as the LotusWorks teams ensured the facility is operating to regulatory standards
• Utilizing Total Preventative Maintenance (TPM), Condition Based Monitoring (CBM) and Lean Maintenance, LotusWorks drive productivity, increase safety on site and decrease the likelihood of equipment downtime
• The client benefits from a risk-based approach which classifies each piece of utility equipment in terms of its impact on product quality ensuring that equipment is prioritized accordingly

The scope of work on this client site has continued to increase and the LotusWorks team continues to add value to the client.