biothermal presentation 4

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

ecosme@biothermalllc.com

CHARLIE NEAL JR.

Compliance Director

CELL 919 622 6396

cnealjr@biothermalllc.com

CHRIS WILKINS

Sales Director

CELL 919 422 8698

chrisw@biothermalllc.com

EDWIN ALEJANDRO

Compliance Manager

CELL 787 387 9003

ealejandro@biothermalllc.com