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OUR MISSION
To provide higher quality services for your organization. After all, we want a long term relationship—not just a one time job.
To create a working environment where one can not distinguish our clients’ employees with Biothermal Consultants by integrating deeply into the work team for one purpose; the project.
To provide cost effective project implementation, surpass any competitive edge by experience, qualifications, cost, quality, timely support, and timeline.
WHY BIOTHERMAL?Biothermal Validation is structured based on a
network of top qualified consultants. By utilizing this concept we assure lower rates than even small companies since we eliminate the overhead cost.
Consultants invited to join our network are selected as follows: Reputation (“word to mouth”) – In such a small
industry the best of the best will eventually be filtered out.
Independent Consultant (leader) – Our people will hit the ground running and ready to provide decision making advices based on gained past experience.
Values – We just don’t fill a position for simply adding a number to our staff; we look for positive solutions on behalf of our clients.
WHY BIOTHERMAL?
We match each task to a consultant with just the right path of experience. Not assigning an over-qualified consultant to a job helps keeping the project cost low.
Biothermal carefully employs consultants with a minimal experience of generally 6 years.
Typically, the rates for a Biothermal Consultant with 6 years experience are much lower than our competitor’s 2 years experience.
COMMISSIONING & QUALIFICATION Validation Certification & Master Plans
Facility Acceptance Test (FAT)
Site Acceptance Test (SAT)
Engineering Studies
Commissioning/De-commissioning
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Technical Writing
QUALIFICATION SERVICES
Facilities and Utilities QualificationHVACWFI/USP/Steam/Air/ NitrogenPressureTemperatureHumidityP&ID Walk-DownDrawings & SchedulesEnvironmentalTransportation Qualification
Temperature MappingWalk-in FreezersCryogenic Freezers/Refrigerators/IncubatorsAutoclave s(Distribution/Penetration/Liquid
loads)Air Tunnels/Depyrogenation OvensSteam Sterilization (Vessels/Transfer Lines/Bio-
Reactors)Warehouse MappingPQ’s
Note: Highly experienced with GE Kaye Validator 2000, Val-probe, and Veriteq VL-2000.
VALIDATION SERVICES
VALIDATION SERVICES (CONT.)
Process ValidationSamplingFMR’s (Batch Records) Review & OptimizationTechnical TransferMedia Fills & TransferInoculationsProduct TransferCharacterizationIQ/OQ/PQ
Equipment QualificationPackaging LineVisual Inspection SystemsFiller/Capper/Checkweigher/LabelerBioreactor/VesselsGranulators/Blenders/Tablet Presser/Capsules FillsAutoclave/Parts WasherLab EquipmentQualification Assessment/Gap Analysis
Cleaning ValidationCIP/SIPParts Washer/ Load ConfigurationSample DropsSwabbing
VALIDATION SERVICES (CONT.)
VALIDATION SERVICES (CONT.)
Computer System ValidationSystem Development Life Cycle
VMP, URS, FRS, SDSRisk AssessmentSOP’s
Security & System Administration, Operational, Backup & Restore, and Disaster Recovery
IQ/OQTraceability Matrix
21 CFR Part 11
DOCUMENTATION SERVICESEngineering Transfer Packages
Template Generation
SOP Development
Field Verification
QUALITY ASSURANCE
GAP Analysis
Risk Assessment
Internal Audits
Change Control Management System
CAPA
cGMP Documentation Review
cGMP Work Plans DevelopmentFDA Consent Decree (483’s) Sites
cLean SERVICES
Streamline Process
Value Stream Mapping
Process Mapping
Reduce Waste & Improve Flow
Improve Communication and Feedback
Standardize Work
Focus on Company Mindset
Lean Manufacturing Training
CONTACTS:
EDWIN COSME
General Manager (CEO)
CELL 919 600 1797
CHARLIE NEAL JR.
Compliance Director
CELL 919 622 6396
CHRIS WILKINS
Sales Director
CELL 919 422 8698
EDWIN ALEJANDRO
Compliance Manager
CELL 787 387 9003
