Select Page

Food and Drug Administration Safety and Innovation Act (FDASIA) and Facility Appearance

by | Jul 28, 2015

Click here for: Foamtec Sahara Plus Cleaning Video

Improving Productivity in Pharmaceutical & Biotech Facilities:
Pharmaceutical and Biotech manufacturing facilities face ever more demanding regulatory and productivity challenges. With the passing of FDASIA legislation, regulatory expectations have increased further making it ever more imperative for facilities to review current practices.
Cleaning SOP’s are an area ripe for review as current practices are typically reactive rather than proactive. Moreover due the FDA’s Lifecycle approach
emphasis the fact that most cleaning and disinfection procedures due to not take into account facility wear increase audit failure and frequency risks. The chart below characterizes the Facility Appearance Cycle and reactive shutdown cleaning that is dictated by current cleaning and remediation practices.
rust chart
Because rinsing protocols are largely ineffective, facility and maintenance engineers can only deal with the buildup of residue, rouge and rust with hazardous chemicals that can only be used during shutdowns (insert link about facility shutdowns). In order to prepare the facility for audits, monthly, quarterly, semiannual and annual shutdowns are built into the calendar. Contract manufacturers often will have monthly shutdowns in place due to the high frequency of customer visits.
Capture
While the ratios vary from plant to plant, the above chart fairly captures the low plant utilization rates that have characterized the manufacturing of Pharmaceutical products.
How do these current practices impede the overall productivity of the facility?
Plants must be shutdown due to the need to bring hazardous passivation chemicals onsite to recondition or re-passivate the stainless steel. Because surface cleanliness and appearance degrade over time until shutdowns, audits, inspections and routine cleanings can be prolonged and made more complicated than is necessary. Which is to say, in addition to productivity shortfalls facilities face severe risks in using current practices. These risks involve the use of hazardous passivation chemicals, which are poisonous to the product and degrading surface cleanliness that can lead to EM excursions.
The Sahara + System™
 
Up until now proactive cleaning has not been feasible due to the inability of Clean Room Mops and Wipers to remove residues from surface using WFI and 70%  Alcohol. To enable proactive cleaning Foamtec has introduced the Sahara + line (insert link to product page) of Clean Room Wipers, Sponges, Mops and Pads that enable technicians to quickly and easily remove disinfectant residues using only DI Water, WFI water, or 70% Alcohol.
Surface Condition Typical with Current Cleaning Practices / Sahara Enables Audit Ready Everyday

3-381b448df3

 
The Sahara + System™ is a production proven process that enables
cleaning staff to remove the disinfectant residues that lead to rust and rouge and which necessitate the expensive and reactive shut down cycle that is the current norm.
The Proactive cleaning enabled by Sahara + Cleaning System leads to less workdays devoted to audits and shutdowns.
Capture2
Optimally Facilities would be in audit ready conditions every day. If this were the case, facility appearance would be represented by the below chart.
Capture3
In Conclusion…
The Sahara Cleaning System Enables improvements in the following areas:
 
Productivity- Shutdowns can be shorter as rust busting is no longer necessary.
 
Safety/Product Purity- Acid based passivation chemistry is no longer required.
 
Risk Reduction- Audits are smoother and particle excursion incidents are reduced as a result of cleaner surfaces.
 
Cost Reduction- Expensive stainless steel equipment need not be replaced or repaired due to corrosion damage.