Benchmark Cleanroom White Paper
White Paper
Introduction
Cleanroom services play a critical role in the chemical logistics industry. These controlled environments provide a contamination-free space to work with and evaluate open product, protect sensitive materials, and minimize the risk of adverse reactions or product degradation.
This white paper explores the critical role and complexities of cleanroom services within chemical operations through:
- Cleanroom management
- Cleanroom services
- Importance and benefits of drip tube exchanges
Cleanroom Management
Maintaining a safe and properly run cleanroom requires a large amount of regulation and training. From the cleanroom itself, to the technicians, to the protocols followed—everything must be up to the proper standards to ensure continued safe and contaminant-free work.
Safety
The safety of the cleanroom is paramount. All of Rinchem’s cleanrooms are ISO Class 5 certified. ISO Class 5 cleanroom safety rules prioritize the use of personal protective equipment (PPE) to protect cleanroom workers, prevent contamination, and maintain a sterile environment. Cleanroom personnel are required to wear appropriate PPE, such as gloves, face shields, coveralls, and full-face respirators, to prevent the introduction of contaminants into the controlled environment and to protect themselves from potential hazards. Additionally, continuous monitoring of temperature and air particle counts is essential to ensure that the cleanroom environment remains within the specified parameters. Regular maintenance of equipment and cleaning procedures are also conducted to sustain cleanliness standards.
gloves
RESPIRATOR
COVERALLS
FACE SHIELD
Rinchem’s Environmental Health and Safety (EHS) team is heavily involved with cleanroom operations. When new chemicals are introduced in the cleanroom, procedures are evaluated to ensure that the safety standard is still met. The EHS team reviews and assesses emergency response plans and procedures specific to cleanroom operations. They verify that cleanroom personnel are trained in emergency protocols, evacuation procedures, and the proper use of safety equipment, such as fire suppression systems or emergency showers. By monitoring these aspects, the EHS team can identify potential risks, maintain compliance with regulatory standards, and implement necessary measures to ensure a safe and controlled environment within the cleanroom. Rinchem cleanrooms are also fully available and compliant for external audits by regulatory agencies.
Training & Certification
Cleanroom employees undergo rigorous training and are required to become certified in many areas before beginning any work in a cleanroom environment. Employees are trained and re-certified yearly in cleanroom operations and procedures. In addition, cleanroom workers undergo health screenings yearly to determine that they are still able to safely carry out cleanroom procedures which are very physically demanding. Cleanroom workers must also re-certify with their respirators every year. They are certified to ensure they are still healthy enough to wear a respirator for extended periods, that their knowledge and utilization of the respirator is up to OSHA safety standards, and to check if the custom fit of their respirator needs any adjustments.
Cleanrooms are also certified yearly. This includes all the equipment in the cleanroom as well as the overall safety of the cleanroom operation. Tools and particle counters are calibrated and all data while work is being performed is stored to ensure no performed work was outside the allowable parameters. Specific work instructions are used to ensure that all cleanrooms across Rinchem meet the same safety standards and maintain their ISO Class 5 certification.
YEARLY CLEANROOM CERTIFICATIONS
- All Equipment Calibration
- Safety Standards
- ISO Class 5 Standards
YEARLY EMPLOYEE CERTIFICATIONS
- Cleanroom Safety and Operations
- Health Screenings
- Respirator Knowledge
- Respirator Fit
Processes
Maintaining a rigorous set of protocols ensures safe and standardized work across all Rinchem cleanrooms. Protocols can also be tailored to customer needs. Not all customers or chemicals will have the exact same set of requirements. Extra steps can be added to specific product or customer protocols that specify torque specifications or O-ring variation. Rinchem also sets a threshold for the maximum number of cleanroom operations that can be completed per day to ensure that employees are not overrun and are able to maintain the high level of product integrity and not sacrifice quality.
The capability to customize how the work if performed, while ensuring that it is performed in exactly the correct way every time is crucial to the integrity of chemicals for both chemical manufacturers and product users.
EMPLOYEE SAFETY
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CLEANROOM SAFETY
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EMPLOYEE CERTIFICATION
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CLEANROOM CERTIFICATION
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STANDARDIZED PROCESSES
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CLEANROOM SAFETY
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EMPLOYEE CERTIFICATION
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CLEANROOM CERTIFICATION
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STANDARDIZED PROCESSES
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HIGHEST CLEANROOM QUALITY
quality
Rigorous safety measures, continuous monitoring, yearly certifications for both employees and cleanrooms, and detailed processes all work towards providing the utmost quality for Rinchem cleanroom services. While a relatively quick cleanroom process may seem simple, the work and training behind the scenes is not so straightforward. The service and quality found in a Rinchem cleanroom are established in complex certifications, rigorous safety measures, continuous training and monitoring, and employee and company expertise.
EXAMPLES OF NON-CONFORMANCE ISSUES FOUND DURING INSPECTIONS
Damage to Vent
Cracked Bung Opening
Foreign Material in Tube
Missing External O-Ring
Crooked Cap Installed
Damaged O-Ring
Cut on External O-Ring
Unseated External O-Ring
Incorrect Cap Installed
Fracture in Tube Threads
Foreign Material in Well
Foreign Material in Container
Cracked Bung Opening
Foreign Material in Tube
Missing External O-Ring
Crooked Cap Installed
Damaged O-Ring
Cut on External O-Ring
Unseated External O-Ring
Incorrect Cap Installed
Fracture in Tube Threads
Foreign Material in Well
Foreign Material in Container
Cleanroom Services
Rinchem provides two main services in our cleanrooms: dip tube exchange and chemical pending inspections. These services can be managed online through Rinchem’s warehouse management system Chem-Star® which reduces time customers spend inputting orders, increases the efficiency and accuracy of work in the warehouse, and provides real-time information and visibility to customers. Rinchem performs approximately 150,000+ dip tube exchanges per year and about 50,000+ inspections a year with 0 quality issues passed on to the end use customer.
pending inspections
Inspections of chemical drums and totes can be performed at Rinchem locations before the product is shipped off to the end user. This service can find and fix a small problem with a product before the product is shipped, saving the supplier and user from having to deal with a much larger problem. This service can not only save chemical suppliers time and money but also improve their working relationship with their clients due to the increase in accuracy and decrease in problems.
Dip Tube Exchange
Dip tube exchange (DTX) is a specialized process within cleanroom services that involves the replacement or maintenance of dip tubes in chemical containers and is a specialized and unique process to Rinchem cleanrooms. Rinchem is the pioneer of dip tube exchange and is the expert for DTX process and techniques and has been performing the process since 1995. Rinchem has 12 facilities that provide dip tube exchange across the world.
12 RINCHEM WAREHOUSES WITH DIP TUBE EXCHANGE CAPABILITIES
There are many benefits to using DTX in chemical supply chains including cost savings, increased efficiency, improved quality, and greater environmental friendliness.
Cost Savings
Dip tube exchange saves suppliers from purchasing a new dip tube for every container they ship to the customer. Instead of having a tube for each container, Rinchem can cycle the dip tubes through the product as they enter and leave the Rinchem warehouse. Instead of the supplier having to purchase 1,000 dip tubes for 1,000 drums, they can have a fraction of the number of dip tubes for the same amount of product.
POTENTIAL COST SAVINGS SCENARIO
Pulling Dip Tubes Out of the Supply Chain
NO DIP TUBE EXCHANGE
DIP TUBE EXCHANGE
TUBED MATERIALS ON HAND
100
50
RETURN TRANSIT
50
0
IN ROUTE TRANSIT
50
0
TOTAL TUBES IN SUPPLY CHAIN
200
50
DIP TUBE AVERAGE COST
$750
$750
TOTAL DIP TUBE COST IN SUPPLY CHAIN
$150,000
$37,500
POTENTIAL COST SAVINGS FOR ONE PRODUCT: $112,500
Increased Efficiency
There is often a shortage of dip tubes in the chemical supply chain—lead times have reached as long as 35 weeks to place a new dip tube. DTX removes this bottle neck as an obstacle entirely. Rinchem uses fleet forecasting to ensure there are always enough dip tubes on hand for products coming into the warehouse. Additionally, in the event of dip tube nonconformance, immediate action can be taken by Rinchem to correct or replace the tube, allowing chemical to still be sent to and used by the end customer without having to be sent back to the chemical supplier.
Improved Quality
Rinchem identified and escalated 119 good catches (cracked dip-tubes, damaged O-rings, leaking containers, missing shipping caps, damages to container, etc.) over the last 3 years to multiple suppliers that could have been Supplier Quality Issues (SQI). During the process of a dip tube exchange, cleanroom employees will check for any quality issues and fix them as needed. Like the pending inspection service, this can not only save chemical suppliers time and money but also improve their working relationship
with their clients due to the increased accuracy and decreased problems. In addition, there is a reduction in risk of damage to tube, torque spec, or container during cross country or global transit that would result in further non-conformance.
Environmental Friendliness
The reduction of risk to the tube during transit provides increased life expectancy of tubes greatly, meaning less tubes need to be made, used, and discarded. This adds to the environmentally friendly aspect of dip tube exchange. Being able to fix non-conformance issues directly in Rinchem cleanrooms is also more sustainable. Rather than having the product shipped from the supplier to the user, finding the issue, shipping the product back to the supplier to be fixed, and then shipping the product back to the
user, or having the product be wasted entirely, Rinchem can simply fix the issue and deliver the product to the user in the proper condition.
Lastly, Rinchem will keep the dip tubes when empties are returned to reuse in the next products, rather than risking the dip tube being thrown away during the processes between the user and supplier.
Conclusion
Cleanrooms play a crucial role in ensuring the integrity and safety of chemical supply chains. By implementing strict protocols, having well-trained employees, and following safety procedures with PPE and monitoring air quality, temperature, and other factors, cleanrooms safeguard against product degradation and contamination-related risks. The adoption of dip tube exchange and pending inspections as a service used by chemical suppliers further enhances these benefits. Significant cost savings, quality improvement, increased efficiency, and environmental friendliness make cleanroom services an invaluable part of a chemical manufacturer’s supply chain.
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