Over the last decade, the FDA has strongly encouraged pharmaceutical manufacturing facilities to standardize and replace manual washing with automated GMP washers capable of generating repeatable results.

While cGMP [1] design standards have been in place for CIP systems for quite some time, The American Society of Mechanical Engineers Bioprocessing Equipment Committee (ASME BPE) recognized the FDA’s increased focus on repeatable cleaning results for clean-out-of-place process items and created a task group to develop design standards for cabinet washers.

Sani-Matic’s Equipment Sales Manager Solo Yang was a member of the task group. He and Pete Barrie, product manager for Sani-Matic, discussed the significance of the committee and the ASME BPE-2016 cabinet washer standards.

“On the committee, we worked with engineering firms, vendors and end-users to make sure everyone was on the same page,” said Yang. “This collaboration allowed us to consider all aspects of the GMP washers, resulting in a more comprehensive and consistent set of hygienic standards for automated GMP Washers.”

“Although automated cleaning with GMP washers has been a standard when manufacturing injectable liquids, we still see some manufacturers within the oral solid dosage (OSD) market with manual cleaning processes in place,” stated Yang.

He continued, “Manual cleaning is an unreliable process that cannot demonstrate a validated, repeatable clean. Companies relying on these methods are at a higher risk of contaminated process parts and products compared to those with automated cleaning processes in place.”

“The goal of the standards is to help pharmaceutical manufacturers implement an automated process that will mitigate that risk of contaminated process parts and product,” stated Barrie.

Barrie added the ASME BPE standards are extensive and should be reviewed closely when deciding to incorporate automated cabinet washers into a plan. He further commented that standards stating “shall” are to be taken as a requirement, while items listed as “should” are strongly encouraged.

He briefly summarized a list of Sani-Matic’s top ten design topics for GMP cabinet washers highlighted in the ASME BPE-2016 design standards for cabinet washers.

Sani-Matic’s Top 10 ASME BPE Design Standards for GMP Washers

  1. The washer shall have racks to hold process parts that are designed for repeatable, validatable coverage. (SD- Internal Components, SD- Spray Device Coverage Test)
  2. Cabinet washers should have the capability for the same phases/steps of CIP systems (pre-rinsing, washing, and final rinsing) along with drying capabilities when required. (SD- Cleaning Cycles, SD- Air Drying, Intake, and Exhaust Systems)
  3. Process contact surfaces and equipment/instrumentation of the washer system’s cabinet and recirculation system need to meet other applicable hygienic design requirements within BPE to the fullest extent possible. (SD- Internal Components)
  4. Final rinses can be done through recirculated or single-pass rinsing. (SD- Rinse Requirements)
  5. Riboflavin coverage testing should be performed on the process contact parts being used in the washer. (SD- Testing)
  6. Riboflavin coverage testing should be performed on any portion of the rack or washer that has the potential to drip back onto the process parts. (SD- Testing)
  7. In general, cabinet washer chamber design and testing should be the same as BPE vessel construction standards. (SD- General, SD- Chamber Openings)
  8. Interface of the cabinet washer exterior with the surrounding installation area should be considered (e.g., surface finish requirements, door interlocking, doors not retracting to uncontrolled maintenance areas). (SD- General, SD- Washer Door and Door Seals)
  9. Cabinet washers can be self-contained with all required equipment for the cleaning cycle, or may receive cleaning solutions from external equipment (e.g., a CIP skid). (SD- General)
  10. Turnover package documentation requirements of the cabinet washer shall meet existing BPE requirements. (SD- Turnover Package Documentation)

Sani-Matic’s GMP washers are compliant with the new ASME BPE-2016 cabinet washer standards. Contact us with any questions regarding your GMP washer needs as they relate to the new ASME [2] BPE standards.