New Parenteral product Formulation and Aseptic Fill Finish facilityIrelandConsultancy Support and Project Guidance throughout including the Contamination Control Process Risk Assessment, URS development, Design Qualification and Requirements Traceability Matrix
Facility Expansion Project for Terminal Sterilisation FacilityIrelandConsultancy Support to Sterility Assurance Risk Assessment and Qualification approach to Sterilisation in Place Processes
Sterilisation Process Improvement on Aseptic Fill Finish FacilityUKAudit and Process Review to ensure regulatory compliance and identify action plans for process improvement.
Training and development of site expertise and Subject Matter Expertise in:-
- Sterilisation and Depyrogenation
- Pharmaceutical Engineering
- Steam Quality Testing
New Filling Line in Parenteral Product Facility for both Aseptic and Terminally Sterilised ProductsUKContamination Control and Cross Contamination Control Process Risk Assessment.
Development of Validation Master Plan, Validation approach and scoping the qualification activities based upon Process Risk Assessment and Design Qualifications
New High Purity Water System; Generation Storage and Distribution for a 45m3/Hr High Purity Water SystemChinaURS Development, Supplier Auditing, Design Qualification and Project support throughout Validation. This project run in conjunction with Crystal Clear Engineering, delivered and led by Mark Thompson Lifesciences
High Purity Water System Upgrade. 18MOhm water system generation storage and distributionUKConsultancy support to scope the most appropriate project solution, URS Development and ongoing consultancy support. This project run in conjunction with Crystal Clear Engineering, deliverted and led by Mark Thompson Lifesciences
Critical Utilities System ReviewNetherlandsAged Plant analysis and Critical Utilities Review in response to FDA observation
Steriliser Upgrade Project to meet current cGMP and EU standards for Sterilisation Processes.BelgiumConsultancy Support and Training for Upgrade Project.
On site cycle development and air detector set up work
Pre US FDA Inspection of Aseptic Fill Finish FacilityIndiaPre Audit inspection and consultancy support in preparation for first site FDA inspection
Biological Indicator Receipt verification. D value testing3 sites in Ireland and 1 in UKReceipt verification of Biological Indicators is defined in USP and EP. Performing independent D value determination is problematic so many sites are changing to running a sub lethal cycle which is in full compliance with EP and USP requirements. Project and Change control assistance being supplied to drive through the change.
Bio burden Control and Micro biology control improvementsBrazilProject Delivered for the Gates Foundation at a vaccine manufacturer in Brazil