Pharmag Pear-Knife Mixer Shaker
| Brand | Pharmag |
|---|---|
| Origin | Germany |
| Model | Pear-Knife Mixer |
| Capacity | 12 L (total), 7 L (usable) |
| Construction | Stainless steel blade and mixing trough |
| Adjustable tilt angle | 0–180° |
| Application | Dry powders, granules, ointments, emulsions |
| Distribution status | Imported via authorized distributor |
| Pricing | Available upon request |
Overview
The Pharmag Pear-Knife Mixer Shaker is a precision-engineered laboratory shaker designed for gentle yet effective homogenization of heterogeneous semi-solid and dry-phase materials. Unlike orbital or vortex shakers optimized for liquid suspensions, this instrument operates on a controlled tilting-mixing principle: a stainless-steel pear-shaped blade rotates within a fixed stainless-steel trough while the entire assembly pivots through a continuously adjustable 0–180° tilt range. This dual-motion architecture generates progressive shear and gravitational tumbling—ideal for achieving uniform dispersion without particle attrition, phase separation, or thermal degradation. Developed in Germany for pharmaceutical process development and formulation labs, it supports scale-down studies aligned with ICH Q5C and Q8(R2) guidelines, particularly for topical dosage forms (e.g., creams, gels, ointments) and solid oral dose blends prior to compression or encapsulation.
Key Features
- Adjustable tilt axis (0–180°) enables precise control over mixing intensity and material flow dynamics—critical for optimizing blend uniformity in low-moisture systems.
- Stainless-steel pear-knife blade and trough ensure corrosion resistance, cleanability, and compliance with ISO 14644-1 Class 7 cleanroom-compatible surface finishes.
- 12 L total chamber volume with 7 L recommended working capacity—engineered to maintain optimal fill ratio (50–60%) for reproducible powder flow and shear distribution.
- Brushless DC motor with closed-loop speed feedback delivers consistent torque across load variations, minimizing batch-to-batch deviation.
- IP54-rated enclosure with interlocked safety door and emergency stop circuit meets EN 61000-6-2/6-4 electromagnetic compatibility and mechanical safety standards.
Sample Compatibility & Compliance
The Pharmag Pear-Knife Mixer Shaker accommodates a defined spectrum of physical states: free-flowing and cohesive powders (e.g., lactose monohydrate, microcrystalline cellulose), granules (dry or moist), hydrophilic/hydrophobic ointment bases, and oil-in-water or water-in-oil emulsions. Its non-impact mixing action preserves particle integrity—making it suitable for APIs sensitive to mechanical stress. The stainless-steel wetted parts comply with USP and EP 3.1.1 requirements for pharmaceutical contact surfaces. Device operation adheres to GMP Annex 15 (Qualification of Equipment) protocols; IQ/OQ documentation packages are available for integration into FDA 21 CFR Part 11–compliant validation workflows.
Software & Data Management
While the base model operates via intuitive rotary encoder and LED interface, optional RS-485/Modbus RTU connectivity enables integration into centralized lab automation platforms (e.g., LabVantage, STARLIMS). All parameter settings—including tilt angle, rotation speed (RPM), and run duration—are logged with timestamp and operator ID when paired with Pharmag’s optional DataBridge module. Audit trails conform to ALCOA+ principles and support GLP/GMP traceability requirements. No proprietary cloud service is embedded; data export is restricted to CSV or PDF formats for internal archival per institutional IT security policies.
Applications
- Pre-formulation blending trials for dermatological products requiring phase stability assessment.
- Homogenization of excipient-API mixtures prior to direct compression or roller compaction.
- Reconstitution support for lyophilized powder formulations where gentle re-wetting is essential.
- QC release testing of semi-solid batches per USP and Ph. Eur. 2.9.35.
- Academic research in colloid science involving structured soft matter (e.g., lamellar phases, polymer gels).
FAQ
Is the Pear-Knife Mixer suitable for sterile processing?
No—it is not designed for aseptic operation or autoclaving. Sterile applications require downstream sterilization of components or use within isolator environments.
Can the tilt angle be programmed in steps or only manually adjusted?
Angle adjustment is manual via calibrated locking collar; no digital preset memory is included in standard configuration.
What maintenance intervals are recommended for the drive system?
Lubrication-free brushless motor requires no scheduled lubrication; annual verification of belt tension (if equipped) and blade-trough alignment is advised per Pharmag Technical Bulletin TB-PMK-07.
Does the mixer meet FDA requirements for equipment used in regulated manufacturing?
Yes—when qualified per GAMP5 and operated within documented SOPs, it satisfies FDA expectations for equipment used in CGMP pharmaceutical production environments.
Is third-party calibration certification available?
Yes—accredited metrology providers offer traceable calibration of tilt angle and rotational speed against NIST-traceable references; Pharmag provides calibration templates for user-executed verification.
