Ultra Clean Surface Technology Process Specification

PALTOP Clean Surfaces are Generated by:
Product and process specifications
Product and process controls
Process verification
Product testing
PALTOP maintains the integrity of the clean concept throughout all processing phases including manufacturing, cleaning, verification and packaging. See process outline above.

Final cleaning is the crucial touch for making ultra high purity product – therefore PALTOP employs a multistage ultra pure water rinsing process prior to assembly, testing and product packaging.

The processes are monitored for consistency and data development for future specifications. PALTOP products, processes and controls are improved continuously in accordance with the specifications that define the current process.

Environmental Monitoring
PALTOP employs clean rooms according to ISO class 7(0.5,5) specification. Clean rooms are constantly monitored for particle and biological contamination in accordance with ISO 14644-1, ISO 14644-3, IES-RP_CC006.3. Particle control shows that PALTOP’s clean rooms are much cleaner than obligated by the standard. Bioburden routine tests show 0-1 CFU per device is way below the standard acceptance criteria of 45 CFU per device.

Ultra-Pure Water Monitoring
The water used for PALTOP cleaning processes are controlled for final conductivity level of 5.5 uS/m. Other properties such as Intermediate resistivity, Bacteria and Particles are monitored to ensure consistent processes.

Digital Control
A designated computerized system ensures full control over process workflow and parameters. Computerized documentation is conducted in accordance with ISO 9001 and ISO 13485 for full traceability and design verification.

Manufacturing with Statistical Process Control
Surface treatment, dimensions and various other product attributes are regulated by PALTOP through a statistical process control. This system ensures continuous monitoring of parts, instead of inspecting finished products – thus ensuring that all parts meet spec limitations. This pro-active approach allows PALTOP to promptly identify manufacturing process changes that could affect products – thus ensuring that adjustments are made so that reject parts are not produced. This “on-line, real-time” monitoring ensures more consistent and reliable products, more efficient production processes, and more competitive pricing as customers do not have to absorb hidden costs of production line problems

Surface Analysis
Routine SEM/EDX (energy-dispersive X-ray) analysis is used to monitor surface purity and morphology This process uses a standardized system of operating parameters to ensure that all the results are consistent.

Material Analysis
Routine X-ray Photoelectron Spectroscopy (XPS) analysis is conducted to assess the surface, ensure the quality of the raw materials and validate PALTOP’s ultra high purity process.