PE Drum (Applitech PE Storage Drum)

Overview

The Applitech PE Drum is a high-purity, single-use compatible polyethylene storage and transport vessel engineered for biopharmaceutical and laboratory applications requiring short-term containment of non-sterile or pre-sterilized liquid media. Constructed from pharmaceutical-grade linear low-density polyethylene (LLDPE), the drum adheres to USP Class VI and ISO 10993-5 biocompatibility standards, ensuring minimal extractables and leachables during contact with cell culture media, buffers, process intermediates, and purification solutions. Its design follows core principles of closed-system compatibility—featuring a smooth, seamless interior surface to prevent particle generation or microbial entrapment, and dimensional consistency across production lots to support repeatable integration with downstream bagging, tubing, and peristaltic pumping systems.

Key Features

• Pharmaceutical-Grade LLDPE Construction: Raw material sourced from certified suppliers; extrusion-molded in a controlled cleanroom environment to ensure batch-to-batch homogeneity and absence of gels, black specks, or surface irregularities.
• Smooth, Non-Porous Interior Surface: Achieved via precision mold polishing and post-molding thermal conditioning—reducing adhesion of proteinaceous residues and facilitating complete drainage (<0.5% hold-up volume).
• Chemical Resistance Profile: Demonstrated compatibility with 70% ethanol, 2-propanol, and aqueous sodium hydroxide (0.1–1.0 M) under ambient wipe-disinfection protocols; validated per ASTM D543-22 for resistance to common sanitants.
• Expandable Rim Design: A precisely dimensioned flange enables secure mechanical fixation of single-use liner bags (e.g., 3-layer EVOH or Tyvek-reinforced PE/PA structures) without adhesive tapes or clamps—supporting rapid setup and minimizing operator intervention.
• Stackable & Pallet-Friendly Geometry: Optimized height-to-diameter ratio (1.8:1) and reinforced base ribbing allow stable stacking up to four units under ISO 8611-1 pallet load conditions (1,200 kg static load).

Sample Compatibility & Compliance

The Applitech PE Drum is routinely deployed for the temporary storage and transfer of mammalian and microbial fermentation broths, formulated media (e.g., DMEM/F12, TB, SOC), chromatography equilibration and elution buffers (e.g., PBS, Tris-HCl, NaCl gradients), and intermediate purification fractions. It complies with ISO 9001:2015 manufacturing controls and supports Good Manufacturing Practice (GMP) documentation packages—including Certificate of Conformance, Extractables Summary Report (per USP <661.2>), and Lot-specific traceability records. While not intended for terminal sterilization, the drum is compatible with gamma irradiation (25–40 kGy) when supplied with validated liner configurations.

Software & Data Management

As a passive containment device, the PE Drum does not incorporate embedded electronics or software. However, it integrates seamlessly into digital manufacturing execution systems (MES) and electronic batch record (EBR) platforms via standardized barcode labeling (GS1-128 compliant). Each unit carries a unique serialized QR code linking to a cloud-hosted quality dossier containing raw material certifications, in-process inspection logs, and final dimensional verification reports. Audit trails comply with FDA 21 CFR Part 11 requirements for electronic records when used in conjunction with validated MES infrastructure.

Applications

• Transport of pre-sterilized cell culture media between upstream preparation suites and bioreactor inoculation points.
• Intermediate hold tanks for clarified harvests prior to depth filtration or chromatography loading.
• Buffer staging vessels in multi-step purification workflows—enabling just-in-time delivery to AKTA or ÄKTA systems.
• Non-sterile blending containers for formulation buffer preparation under ISO Class 7 cleanroom conditions.
• Secondary containment for single-use bioprocess bags during manual handling or mobile cart transport.

FAQ

Is the PE Drum suitable for sterile applications?
No—it is designed for non-sterile or pre-sterilized content handling only. Sterility must be maintained by the liner or upstream processing steps.
Can the drum be autoclaved?
No. Polyethylene softens above 110°C; autoclaving will cause deformation and compromise structural integrity.
What liner materials are validated for use with this drum?
Standard validation includes 3-layer PE/EVOH/PE and Tyvek®-reinforced PE/PA coextruded films—full compatibility reports available upon request.
Does Applitech provide custom labeling or serialization services?
Yes. GS1-compliant label printing, QR code embedding, and integration with customer LIMS/MES systems are offered as value-added options.
What is the maximum recommended fill level for safe transport?
For optimal stability and minimal sloshing, maintain fill level at ≤85% of total volume when transported on standard ISO pallet jacks or automated guided vehicles (AGVs).