| Materials
Inspected for tubing, fittings, valves, regulators,
and other components Include: |
Metallic Materials
| > |
Stainless steel alloys (mechanically and/or electropolished),
316L, 304 |
| > |
Nickel alloys [Hastelloy, Hastelloy C, Inconel] |
| > |
Super-Moly alloys - AL-6XN |
| > |
Copper |
| > |
Carbon steel |
|
Non-Metallic Materials
| > |
Polyvinylidene fluoride (PVDF) |
| > |
Polypropylene (PP) |
| > |
Polyvinyl Chloride (PVC) |
| > |
Teflon |
| > |
Chlorinated Polyvinyl Chloride (CPVC) |
|
|
FST provides experienced,
trained manpower and state-of-the-art equipment to meet
customer quality assurance objectives while satisfying
internal specifications and procedures and the site-specific
cGMP compliance program to meet FDA standards for validation.
Our bio-pharm services include:
Consulting
|
|
Project
Management |
|
Inspection |
| • |
Specification review |
| • |
Installation drawings review |
| • |
Construction materials review |
| • |
Installation procedures generation or review |
| • |
Installation protocols generation or review |
| • |
cGMP compliance |
| • |
Visual acceptance stds |
| • |
Testing criteria & acceptance |
| • |
Hazardous materials |
|
|
| • |
Manpower & equipment utilization |
| • |
Schedule planning |
| • |
Contingency planning |
| • |
Risk assessments |
| • |
High return QA/QC activities |
| • |
Budget and cost control |
| • |
Safety execution and performance |
|
|
| • |
Material supplier audits |
| • |
Source inspections |
| • |
FATS and SATS |
| • |
Prefab verification |
| • |
Cleanroom certification |
| • |
Welder qualification |
| • |
Weld inspections |
| • |
Borescope inspections |
| • |
Slope verification |
| • |
NDE |
| • |
Remediation oversight |
|
| |
|
|
|
|
| Training |
|
Testing |
|
Documentation Control |
| • |
cGMP compliance program |
|
|
| • |
Gas/liquid acceptance testing |
| • |
Installed process water systems |
| • |
>
TOC analysis |
| • |
> Resistivity |
| • |
> Particles |
| • |
Radiographic testing |
| • |
Lab analysis interpretation |
| • |
Testing value assessments |
|
|
| • |
Material Control – at source, on site receiving |
| • |
Reports, logs, ISO drawings, for cGMP compliance |
| • |
Cleaning/Passivation documentation |
| • |
Turnover package |
|
|
