Coexcell Employee Orientation Centers

On Nine Critical Processes
We recognize and promote the important role played by each of our employees in providing our pharmaceutical and chemical industries customers with contaminant free bulk packaging.

To address the critical needs of our customers and assure them the purest drum products available, we have developed proprietary manufacturing capabilities around a Nine Critical Processes approach. To assure its success, we have indoctrinated every employee as to their importance to securing and keeping business and jobs. It goes beyond indoctrination though. It includes end-to-end quality assurance via constant oversight and consistent prompting.

The first step in the process is checking in the raw material and securing the storage for use. This is truly critical to get the entire process off on the right foot. The raw materials used for ultra-high purity drums are checked in and tested and then stored in virtual clean room conditions for ongoing production uses. Even the movement from storage to production line is done in a secure process.

Facility cleanliness and meticulous mechanical maintenance are also high up on COEXCELL procedurals. We adhere to a very strict schedule of proactive maintenance of both facility and all production equipment and machines. Every aspect of ultra-high purity drum production requires stringent discipline to assure contaminant free output. This attention with a commitment to constant, continuous improvement of all facets of production results in a superior product.

Receiving Process

  • Only Vendors who have been qualified under the USC Approval Process
  • Certificates of Analysis for Resins upon delivery
  • Certificates of Conformance and visual inspection for Component Parts upon delivery
  • Completion of documentation to insure traceability throughout manufacturing
  • Control of internal regrind to insure traceability to original virgin feed stock

Storage Process

  • Storage conditions that insure the preservation of the purity of the product as delivered and accepted.
  • Storage conditions that insure a “first-in first-out” draw-down of stock.

ICAS™ at a Glance

  • ICAS™ enables the use of specialty resins for the liner layer of multilayer drums, to achieve the lowest possible metallic extractables.
  • ICAS™ manufacturing technology is directly integrated in the blow molding process where it effectively measures and controls the size and quantity of air-born particulates throughout container formation, producing an ultrapure interior.
  • Per ICAS™ protocol, the post-forming area is a Class 1000 Clean Room which assures drum purity during final finishing. Finished product samples are moved to our in-house Class 100 clean room laboratory for a liquid particle test to certify drum cleanliness

 

Additional ICAS™ Protocols

  • All ICAS™ technicians are fully and extensively trained, tested and monitored
  • Within clean room and test room environments, gowns, bonnets, gloves, and masks are worn at all times
  • Clean Room equipment is maintained regularly, tested frequently and monitored 24/7
  • All ICAS™ clean and test room surfaces are cleaned on strict schedule within enforced guidelines

ICAS™ Key Manufacturing Control Elements

  • Long Range Production Scheduling for each Machine
  • Work Instructions, Machine & Job Control Documents
  • Documentation creates a Traceable Chain of Responsibility
  • Lot Traceability of Materials and Components
  • Unique Date Time Stamp on each Drum
  • ICAS™ quality tested drums are certifiable to a particle count consistent with customer specifications

Objective and Commitment

  • The Objective of our End-to-End Quality Assurance program is to insure that we consistently and continuously produce and ship the purest drums in the world.
  • To achieve this requires an extraordinary level of Commitment to an intelligently designed, totally transparent and completely traceable Quality Assurance Process, which is rigorously enforced.

ISO Certification

  • COEXCELL has been re-certified in accordance with ISO 9001:2015 standards. This re-certification is symbolic of the ongoing quality commitment of Coexcell’s entire staff.

UNDOT Certification

  • UNDOT Certification requires that the drum being certified meets UNDOT Certification standards for five specific tests,
  • Drop Test
  • Hydrostatic Pressure Test
  • Leak-Proof Test
  • Stack Test
  • Vibration Test
  • COEXCELL is capable of conducting all but the Stack and Vibration Testing “in-house”, which is conducted off-premise by a certified third party.

Annual UNDOT Re-Certification

  • All UNDOT Certified Drums must, by “regulation”, be recertified annually by successfully conducting the original certification test a specified number of times during the year. The only exception is the Stack and Vibration Test which may be (and is) conducted “in-house” as a dynamic load test.
  • Recertification Tests Required by UNDOT =  6 per year
  • Recertification Tests Performed by USC =  +120 per year

Test and Inspections During Production Runs

  • A leak-proof test on every drum, per UNDOT Regulations, on a pressure stand with calibrated testing equipment.
  • A visual inspection of the drum is performed to detect any clearly visible internal and/or external flaws.
  • Photographic Analysis during sidewall testing 2x per shift.
  • Liquid Particle Count test 2x per production run.
  • Full Drum Measurement and all Layer Thickness 2x per shift.
  • Hourly Machine Process Control Checks
  • Blown Air Purity inspection prior to Ultra-Pure runs.
  • Clean Room air and housekeeping inspection prior to Ultra-Pure runs.

Record Keeping Overview

  • Raw Material & Component lot traceability records
  • Full UNDOT test records for each production run.
  • Product Consistency records for each production run.
  • Certificates of Analysis for each production run as required.
  • Quality Control Data for Control Limits Performance
  • Quarterly Liquid Particle Count (LPC) reports and Statistical Quality Control (SQC) reports.
  • Overall Equipment Effectiveness (OEE) data.
  • Failure Mode Effect Analysis data.
  • Tool and measurement device calibration records.
  • Sampling Plan records.

COEXCELL maintains a high level process and is procedure driven to govern the introduction of any change

  • Coordination with the customer on all changes.
  • Review and understanding of Customer’s and End Users’ change control protocol.
  • Thorough risk assessments are performed.
  • Change control is managed as an Agenda Item at every Management Review Meeting.

One of our Core Values is a commitment to remain ahead of the performance curve, by maintaining a culture of continuous improvement.

Some ways by which we accomplish this are:

  • Adopting new and better testing equipment and methods as they become available. Such as Small Volume Testing for targeted chemistries.
  • Integrating new HEPA advances into ICAS™.
  • Our PIQ (Production Improvement Quality) Team explores ways to increase production efficiencies and product quality
  • Keeping abreast of advances in the Blow-Molding Industry and adapting wherever and whenever appropriate
  • Dedicating capital to plant, machine and process improvement.

Research and Development is a parallel activity with Continuous Improvement, that is focused on creating new products and even new product lines. Although information on products under development is proprietary some recent developments have been:

  • Conductive drums
  • X and Y rated open head drums for Hazardous Waste
  • Drums with Higher Hydrostatic Pressure ratings and /or Higher Packaging Group Equivalencies.

The Quality of our product and the efficiency of our processes are directly proportional to the level at which we maintain our machinery, equipment and our facility. To insure they are always maintained at the highest levels possible we:

  • Maintain an aggressive Preventative Maintenance program for our all of our machinery and equipment.
  • Are always prepared for Reactive Maintenance scenarios.
  • Pay particular attention to Air Purity & HEPA Filtration systems and all proprietary equipment used in ICAS™
  • Maintain a rigorous Housekeeping and Cleaning Program

Akin to Mechanical and Facility Maintenance, the level of Product Quality and Operational Efficiency is driven by technical competency of the personnel who build and test the product. To that end, COEXCELL invests heavily in the human factor, by:

  • Providing continuous training and education of personnel.
  • Continuous development and documentation of training requirements and materials

Measuring the effectiveness of the training and modifying it as necessary

Driven by one of our Core Principals – “Instilling a Customer Centric Orientation, consistently outstanding Customer Service and Support is our goal.” We achieve this by:

  • Promoting open and frank Communication and Feedback with our Leads, Prospects and Customers.
  • Offering a simple and efficient design control process
  • Quickly providing Quotations, Test Data, Samples, Lead Times, Logistical Support and Order Confirmations.
  • Invite customers and prospects to see the facility for themselves and make their own determination.
  • Always listening to, and hearing, the “Voice of the Customer”
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