spec@team-spec.com

Biopharmaceutical and Medical Device Wet Process Systems

Biopharm plate processor

Making medical devices, biologic, and pharmaceutical products presents manufacturers with special challenges.biopharmeceutical Glass wafers Tooling and fluid handling components must be made from approved materials and engineered for long life in production. Work in process must remain pure and separated from airborne contamination. 

Control systems must be in compliance with FDA regulations for logging and data security including CFR Title 21. Maintenance activities must be effective with a minimum of technician labor. 

SPEC’s ALT series automatic tools are perfectly suited to these requirements.  Each system is custom tailored to fit the substrate or medical device precisely while performing the exact wet process sequence necessary. 

Linear robotics typically handle batches of parts in carriers.  In the tool shown here, glass discs are loaded into specially designed transport cassettes, then are automatically immersed through a series of chemical solutions.  Robotics for individual items are available.

Biopharm plate processor HMI

Operators use barcode readers to enter lot numbers and verify recipe selection on the touch-screen controller.  Multiple recipes are available for simultaneous and independent operation.  Critical to Quality data points as well as process sensor outputs and operator alerts are logged locally; remote reporting is available. 

Biopharm plate processor interior

Solutions are automatically blended from on-board storage reservoirs and reagent bottles into stations made of quartz, PFA, PVDF, stainless steel or other approved materials.

Automatic lids reduce evaporation and assist with temperature stability.  Reduced oxygen content processing can be achieved via nitrogen purge distribution incorporated within the lids. Recirculation with filtration assures cleanliness is maintained.

 

Call for more information... 661-257-0934

  • Chemical temperatures are controlled during use and while stored at elevated or sub-ambient as needed. 
  • ALT Series automatic wet benches are compatible with ISO Class 3 clean-rooms and can be equipped with integrated UPLA or HEPA fan filter units for maximum product security. 
  • Bulkhead mounting through the clean-room wall is typical allowing segregation of process and service environments.
  • Generous rear access panels give easy access to filters, process piping and chemical reservoirs. All interior surfaces on this tool are welded plastic and suitable for wash-down and disinfection.  
  • Materials of construction can include FM-4910 listed and rated plastics as needed.  Full stainless steel systems are also available.
  • System as shown is 108” long X 54” deep X 90” tall.  The quantity of process stations and other features will affect final dimensions; specifications subject to change without notice.