Microstar is a privately owned company formed in 1991 to provide services to the Healthcare Industry. The company is dedicated to the Pharmaceutical and Biopharmaceutical sectors specialising in Engineering, Qualification and Validation of the following areas:
- Facilities
- Utilities
- Equipment
- Primary Manufacturing processes
- Secondary Manufacturing processes
- Packaging and Warehousing
- Storage and shipping
- Laboratories
- Computer systems
Microstar offer a single source approach to Pharmaceutical projects, with services offered to support conceptual feasabiltiy/design through to project delivery/hand-over. Microstar have managed, engineered and validated projects for major Pharmaceutical companies and have skills in the following major areas:
- Oral Liquids
- Solid dosage (Tablets & Capsules)
- Topicals (Creams & ointments)
- Parenterals (aseptic sterile manufacture)
- Metered Dose Inhalers (MDI’s)
- Packaging (All dose forms)
- Active Pharmaceutical Ingredients (API’s)
- Biopharmaceuticals / Biotech
- Laboratories
- IT/IS
Microstar provide services to our clients by partnering with the client's staff at all levels. In this way we can scope our activities to the specific requirements and provide a cost effective service. Some of the specific skills available to our clients include:
- Project & Program Management
- Project Engineering
- Feasibility studies
- Company/site GMP & Quality audits
- Computer/control system audits
- Quality System development and implementation
- System Development Life cycle (SDLC) for computer validation projects
- Specification preparation
- System design and development to current standards
- Impact assessments
- FMEA facilitation.
- Validation consultancy
- Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
- Factory Acceptance Testing (FATs) (review, preparation and or execution)
- Site Acceptance Testing (SATs) (review, preparation and or execution)
- Process Validation (PV)
- Cleaning Validation (CV)
- Implementation of procedures and standards
- MHRA/FDA inspection readiness and audit support
- Testing and commissioning
- Training
- Production support
We have been engaged as Validation Service Provider and engineering projects service provider for major pharmaceutical companies for many years. Reference sites and referees are available.