Sartorius Sartolab® Bottle Single-Use Sterile Polystyrene Storage Bottle

Overview

The Sartorius Sartolab® Bottle is a single-use, sterile, medical-grade polystyrene (PS) storage container engineered for the safe, reliable, and contamination-controlled handling of sensitive biological liquids in life science laboratories. Designed specifically for applications requiring strict sterility assurance—such as cell culture media, fetal bovine serum (FBS), PBS buffers, enzyme solutions, and other aqueous reagents—the Sartolab® Bottle eliminates the need for autoclaving, cleaning validation, or repeated sterilization cycles. Its pre-sterilized state (gamma-irradiated, validated to ISO 11137), combined with low extractables and endotoxin-free construction (<0.03 EU/mL), ensures compatibility with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and USP requirements for parenteral and bioprocessing workflows.

Key Features

• Medical-grade virgin polystyrene (PS) body: chemically inert, non-pyrogenic, and free of animal-derived components—certified compliant with USP Class VI and ISO 10993-5 biocompatibility standards.
• Ergonomic 45 mm screw cap with integrated silicone gasket: delivers consistent, gas-tight sealing performance across freeze-thaw cycles and long-term refrigerated (2–8 °C) or frozen (−20 °C / −80 °C) storage.
• Optimized bottle geometry: compact footprint with recessed base enables stable vertical stacking—reducing footprint by up to 40% in cold rooms and ultra-low temperature freezers.
• High-contrast, laser-etched volume graduations (±2% accuracy at 20 °C): calibrated for upright orientation and readable under standard lab lighting conditions.
• Dedicated labeling zone on shoulder: compatible with permanent solvent-resistant markers and thermal-transfer barcode labels (e.g., Brady® or Zebra® certified media).
• Neck compatibility: standardized 45 mm thread interface ensures seamless integration with Sartorius Sartolab® RF and BT vacuum filtration units—enabling direct sterile transfer without intermediate decanting.

Sample Compatibility & Compliance

The Sartolab® Bottle demonstrates broad chemical compatibility with common aqueous-based biologics, including DMEM/F12, RPMI-1640, HEPES-buffered saline, trypsin-EDTA solutions, and IgG-containing formulations. It is not recommended for use with strong organic solvents (e.g., acetone, chloroform) or highly concentrated acids/bases (>1 M). All lots undergo rigorous quality control per ISO 9001 and ISO 13485 protocols, including bioburden testing, particulate analysis (USP ), and extractables profiling per ICH Q5C guidelines. Sterility is confirmed via membrane filtration (ISO 11737-2) and supported by full traceability documentation (CoA, CoO, and irradiation dose report).

Software & Data Management

As a passive consumable device, the Sartolab® Bottle does not incorporate embedded electronics or software interfaces. However, its design supports digital lab infrastructure through standardized physical identifiers: each unit carries a unique lot number and product code (e.g., 180-22-E) compatible with LIMS (Laboratory Information Management Systems) and ELN (Electronic Lab Notebook) platforms such as LabVantage, Benchling, or Veeva Vault. Optional QR-coded label kits (sold separately) enable automated inventory tracking, expiration date monitoring, and audit-ready chain-of-custody logging aligned with FDA 21 CFR Part 11 electronic record requirements.

Applications

• Pre-aliquoted storage of serum supplements and growth factors prior to cell line expansion.
• Cold-chain transport of clinical-grade buffers between QC labs and GMP manufacturing suites.
• Intermediate hold vessels during downstream purification steps in monoclonal antibody production.
• Storage of calibration standards and reference materials in ISO/IEC 17025-accredited testing laboratories.
• Decentralized distribution of media batches across multi-user core facilities—minimizing cross-contamination risk in shared incubator environments.

FAQ

Are Sartolab® Bottles suitable for long-term cryogenic storage at −80 °C?
Yes—validated for continuous storage at −80 °C; however, avoid mechanical shock during retrieval to prevent microfracture formation in the PS matrix.
Can these bottles be used under positive pressure (e.g., nitrogen overlay)?
No—they are designed for ambient or slight negative pressure only; use Sartorius Pressurized Storage Systems for controlled headspace applications.
Is the bottle material compliant with REACH and RoHS directives?
Yes—full substance declaration available upon request; no SVHCs above threshold concentrations per REACH Annex XIV.
Do you offer custom labeling or private branding options?
Yes—Sartorius offers OEM labeling services with minimum order quantities; contact authorized distributors for regulatory-compliant artwork approval workflows.
What is the shelf life post-sterilization?
36 months from manufacture date when stored unopened in original packaging at 15–25 °C and ≤60% RH; see Certificate of Analysis for lot-specific expiry.