Sterile Multi-Use Diluent: Research and Application Guide

Introduction

The Sterile Multi-Use Diluent is designed to meet the rigorous demands of preclinical research and experimental protocols. It provides a highly controlled, sterile, and non-clinical vehicle for investigational formulations. This document serves as a comprehensive guide to its composition, quality assurance, and application within research settings.

The diluent's multi-use capability is a critical feature, allowing researchers frequent, repeated access to a sterile solvent from a single container. This design minimizes the risk of microbial contamination, which is often associated with traditional single-use or high-access solvents, thereby ensuring the consistency and integrity of dosing and formulation preparation across multiple experimental time points.

I. Research Context and Application

This diluent is engineered specifically for use in experimental and preclinical environments where formulation purity and sterility are paramount.

A. Vehicle for Investigational Formulations

In experimental environments, the Sterile Multi-Use Diluent serves as a reliable vehicle for non-clinical investigational formulations. Its neutral pH and isotonic characteristics are suitable for use with a wide range of compounds, ensuring the stability and biological relevance of the dissolved agents.

Application Type

Research Focus

Key Benefit

Preclinical Dosing

Pharmacokinetics/Pharmacodynamics (PK/PD) studies

Facilitates precise, consistent dosing in animal models

Drug Stability Testing

Formulation Optimization

Provides a stable, inert solvent for stress-testing compounds

Compound Resuspension

High-Throughput Screening (HTS)

Ensures complete and sterile dissolution of powdered compounds

B. Cell Culture and Buffer Systems

Beyond serving as a primary vehicle, the high purity of this formulation makes it an excellent choice for:

• Cell Culture Media Supplementation: Used to dilute or resuspend supplements, ensuring the final culture environment remains sterile and free of confounding contaminants.
• Buffer System Formulation: Serves as a base for custom buffer solutions used in protein purification, electrophoresis, and general molecular biology protocols.

II. Product Specifications

The diluent is manufactured and packaged to support high standards of purity and usability in a laboratory setting.

A. Formulation and Components

The diluent is an aqueous, isotonic solution. The full, proprietary list of excipients is maintained in the File, but the general characteristics are as follows:

• Sterility Assurance: Manufactured and filled under current Good Manufacturing Practice (cGMP) conditions and terminally sterilized.
• pH: Maintained within a narrow range (e.g., 7.0–7.4) to match physiological conditions.
• Osmolality: Isotonic (e.g., 280–310 mOsm/kg) for compatibility with biological systems.

B. Microbial Inhibition Feature

A critical feature is the inclusion of a validated antimicrobial system that ensures consistency across repeated access events. This system provides a margin of safety against common laboratory contaminants that might be inadvertently introduced during frequent use.

• Mechanism: The inhibitory agent prevents the proliferation of bacteria and fungi after the first puncture of the vial septum.
• Efficacy: Tested against USP (United States Pharmacopeia) microbial challenges and demonstrated to maintain sterility for up to 28 days following initial access, provided proper aseptic technique is followed.
• Compatibility: The concentration of the inhibitory agent is non-interfering with most common cell lines and investigational agents at typical dilution ratios. A full compatibility report is available in the Quality Control appendix, File.

III. Quality Control and Validation

A. Sterility Testing

Each lot of the Sterile Multi-Use Diluent undergoes rigorous sterility testing prior to release.

Test Parameter

Standard

Acceptance Criteria

Endotoxin Level

LAL (Limulus Amebocyte Lysate) Assay

Less than 0.25 Endotoxin Units (EU) per mL

General Sterility

Direct Inoculation Method (USP <71>)

No microbial growth observed at 14 days

Sub-visible Particles

Light Obscuration Method

Meets USP <788> standards for Large Volume Parenterals

B. Multi-Use Validation Study

A study was conducted to validate the efficacy of the microbial inhibition feature over multiple accesses.

1. Procedure: Vials were spiked with low concentrations of common laboratory contaminants (e.g., S. aureus, C. albicans) immediately following the first puncture.
2. Access Simulation: Vials were accessed daily over a 28-day period using a sterile syringe and needle.
3. Result: The diluent consistently demonstrated the ability to inhibit microbial growth, confirming its suitability for multi-use application. The detailed report of this validation is filed as File.

IV. Handling and Storage Protocols

To ensure the integrity of the diluent, researchers must adhere to strict handling and storage procedures.

A. Aseptic Technique

Strict aseptic technique is mandatory when accessing the diluent. Failure to comply may compromise the inhibitory system and invalidate the product’s sterility assurance.

• Preparation: Clean the rubber septum with a sterile, single-use alcohol swab (70% isopropyl alcohol) and allow it to air-dry completely before puncture.
• Access: Use a sterile, disposable needle and syringe for each withdrawal.
• Disposal: Do not recap or reuse needles.

B. Storage Requirements

• Temperature: Store at controlled room temperature (20°C to 25°C [68°F to 77°F]). Excursions permitted between 15°C and 30°C (59°F and 86°F).
• Protection: Protect from direct light. Do not freeze.
• Post-Access Tracking: Once the vial has been punctured, record the date and time of first access on the vial label. The contents should be discarded 28 days after the first access.

V. Ordering and Support

For technical inquiries regarding the diluent's compatibility, or to schedule a consultation on integrating this diluent into a specific protocol, please contact Person at the Technical Support Office.

All orders and product availability questions can be directed to the dedicated team via this link: .

Information

Details

Product Code

SMD-500

Standard Size

500 mL glass vial

Shelf Life (unopened)

Date

Technical Support Event

Schedule a follow-up meeting to discuss integration here: Calendar event