To Wipe or Not to Wipe: A Guide to Material Handling in a Sterile Compounding Cleanroom

Material Flow: From Delivery Dock to Pharmacy

The presentation begins at the loading dock to illustrate where materials first enter a facility. Shipments typically arrive in outer packaging and cardboard boxes, which can carry contaminants from shipping environments.

The webinar highlights the importance of establishing a controlled process for transferring materials from the receiving area to the pharmacy.

Risks Associated with Shipping Materials and Cardboard

Corrugated cardboard is identified as a significant contamination risk. During transportation and storage, cardboard can accumulate microorganisms, dust, and environmental contaminants.

Because of this risk, cardboard packaging should not be brought into pharmacy cleanroom environments. Allowing cardboard to enter controlled areas may introduce unwanted contamination.

Best Practices for Removing Outer Packaging

The recommended best practice is to remove products from cardboard shipping containers before they reach the pharmacy or cleanroom areas.

Materials should be transferred from cardboard packaging into clean, non-shedding containers such as plastic totes. These containers can then be safely transported into pharmacy areas while minimizing contamination risk.

Preparing Materials for Cleanroom Entry

Once materials are brought into the pharmacy area outside the cleanroom, additional preparation is required before they enter controlled environments.

This preparation involves inspecting packaging integrity and preparing items for surface disinfection in accordance with USP <797> guidance.

Facilities must ensure that packaging is intact and capable of being disinfected without compromising product integrity.

USP <797> Requirements for Introducing Materials

Section 8.1 of the revised USP <797> chapter provides specific guidance on introducing materials into controlled areas.

Before items are introduced into:

• The clean side of the anteroom
• A pass-through chamber
• A segregated compounding area (SCA)

- they must be disinfected if packaging integrity allows.

This step is essential for preventing contamination from entering sterile compounding environments.

Disinfecting Materials Before Entry

USP <797> specifies that materials must be wiped using one of the following:

• A sporicidal disinfectant
• An EPA-registered disinfectant
• Sterile 70% isopropyl alcohol (IPA)

Personnel performing this task must wear gloves and use appropriate wipes to disinfect the item’s outer surface before it enters the clean area.

The wiping step reduces the microbial load on incoming materials.

Pass-Through Chambers and Alternative Workflows

The chapter references pass-through chambers as a method for transferring materials between spaces while maintaining environmental separation.

However, many cleanrooms do not have pass-through chambers. In these cases, facilities must establish alternative workflows that still meet contamination control requirements.

Regardless of infrastructure, materials must be disinfected before entering controlled spaces.

Material Handling Inside the Cleanroom and PEC

Once materials enter the cleanroom environment, further care must be taken when introducing items into the PEC.

Personnel must maintain aseptic technique and ensure that materials entering the PEC do not compromise airflow or contamination control.

Proper material handling procedures are critical for maintaining sterile compounding conditions.