Cleanroom Polymer Processing & Controlled Manufacturing

Molding and assembly in ISO 14644 cleanrooms: particle generation from polymers and equipment, gowning economics, process validation, and the molder-transfer playbook that decides CDMO relationships.

Private cohorts & on-site
Format: 2-day (8:30 a.m.–4:30 p.m.)
Level: Intermediate-Advanced
Location: Scheduled on demand · on-site at your facility or a regional venue
Date(s): Not yet scheduled for open enrollment. Get notified when it is, or book it privately for your team.
Includes: Certificate of Completion · printed slide binder · take-home reference text

Get notified when this course is scheduled

One email when dates are set. Or skip the wait: run it as a private cohort, on-site at your plant.

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Faculty

Faculty details for this seminar will be announced with the full schedule.

Fees

Early: $1,895 (payment 4+ weeks ahead)
Standard: $2,095 (check/ACH) · $2,165 (card)

Group discount: $200 off per attendee for 3+ from the same organization.

Also Available

  • Corporate on-site delivery at your facility
  • Private cohort sessions
  • Digital curriculum licensing

Seminar Overview

Cleanroom manufacturing is where medical molding economics live or die — and it's taught nowhere: ISO 14644 classifications, particle generation from polymers and equipment, gowning costs, and the validation documentation that turns a cleanroom into a compliant one. This seminar teaches controlled manufacturing from the process engineer's seat: what each ISO class actually requires, how molding and assembly generate particles (and how to design against it), the gowning and material-transfer disciplines that keep a class 7/8 room honest, and the validation/transfer documentation architecture.

The CDMO half is the money module: transferring a molded program between molders without destroying qualification, the multi-customer data segregation problem, and the documentation that survives a customer audit. Packaging (M-05) and sterilization (M-01) interlocks are made explicit: what the cleanroom owes the barrier, and what the barrier owes the room.

Segment demand: Integer Holdings (largest US CDMO), Conmed, Welch Allyn, Brainlab, Sysmex, and every ISO 13485 molder in the estate's medical cluster — with 'cleanroom' previously appearing zero times in the catalog corpus.

Ideal Learner

  • Process engineers in or entering cleanroom molding/assembly
  • CDMO engineers managing multi-customer programs
  • Quality engineers owning cleanroom validation
  • Manufacturing engineers planning cleanroom capacity

Learning Objectives

  • Read ISO 14644 classifications and specify a room class per process honestly
  • Identify and control polymer/equipment particle sources in molding and assembly
  • Design gowning, material transfer, and flow that keeps a class 7/8 room compliant
  • Assemble the validation and transfer documentation for a molded program
  • Execute a molder-transfer without destroying qualification

Consulting Sessions

Seminar attendees can sign up for individual consulting sessions with the instructor. Sessions are free for registered attendees, first-come first-served — sign up when registering by calling 248-539-0473 or during the seminar.

Seminar Outline

  • ISO 14644 classes and what each requires
  • Airflow, pressure cascades, and monitoring
  • Class 7/8 molding: what changes vs. standard shop floor
  • Where particles come from: polymer dust, mold release, wear
  • Equipment selection and maintenance for cleanroom service
  • Assembly processes: ultrasonic welding, staking, printing in the room
  • Designing the process to generate less
  • Gowning discipline and its economics
  • Material transfer: airlocks, wipe-down, documentation
  • Behavioral failure modes: the audit findings that repeat
  • Process validation in cleanroom context
  • The molder-transfer playbook: what transfers, what requalifies
  • Multi-customer data segregation (CDMO core problem)
  • Surviving the customer audit: the documentation trail
  • Cleanroom capacity economics: class vs. cost
  • Cleanroom-Build/ChatETS integration: documentation as a system
  • Workshop: plan a class-8 molding cell for a device housing

More in Track M — Regulated-Product Design

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