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Key: test item, instrument name, total nonvolatile migration, gravimeter, moisture permeameter

Product

Drop Ball Impact Tester for Pharmaceutical Rigid Packaging

STQ-B
Focusing on packaging and material testing technology, we are committed to quality control in industries such as healthcare, pharmaceuticals, food, packaging, textiles, and new materials. Our products are widely used in enterprises, testing institutions, universities, and research institutes.

Category:

Packaging and Printing

Impact Resistance

Drop Ball Impact Tester for Pharmaceutical Rigid Packaging & USP <661.2> Evaluation

Overview

The LabStone Drop Ball Impact Tester is a precision laboratory instrument engineered to evaluate the impact resistance of pharmaceutical rigid containers, PVC/PVDC blister films, aluminum‑plastic caps, and medical-grade security glazing.

Designed specifically for labs requiring USP <661.2> (Plastic Packaging Systems) and USP <382> (Elastomeric Components) functional evaluation, this instrument uses a globally recognized free‑fall method (ASTM D3029) to generate quantitative impact energy data. It is the ideal solution for pharmaceutical packaging manufacturers, CMOs, CROs, and QC laboratories demanding audit‑ready documentation and repeatable results.

Key Functions

Determine the impact resistance of pharmaceutical rigid containers, aluminum‑plastic caps, and infusion bottle closures.

Evaluate the toughness and fracture behavior of PVC/PVDC rigid sheets and blister‑forming films.

Generate empirical impact energy data to support USP <661.2> and USP <382> functional performance dossiers.

Perform high‑throughput QC testing with automatic energy calculation, statistical analysis, and printed reports.

Test Principle

A calibrated steel ball is held by a precision electromagnetic sucker at a user‑defined height (25–900 mm). The specimen is securely clamped on a pneumatic platform with uniform pressure. Upon de‑energizing the electromagnet, the ball falls vertically and freely onto the specimen. The operator observes whether the specimen cracks, punctures, or fractures. The instrument automatically calculates the impact energy (N·m) from the ball mass and drop height, then prints a detailed report including mean, variance, ball specifications, drop height, and sample thickness.

Compliant Standards

ASTM D3029‑21 — Standard Test Methods for Impact Resistance of Flat Rigid Plastic Specimens by Means of a Falling Weight(Method F — free‑fall ball)

ISO 6603‑2:2000 — Plastics — Determination of puncture impact behaviour of rigid plastics — Part 2: Instrumented impact testing(reference for energy calculation principles)

USP <661.2> — Plastic Packaging Systems for Pharmaceutical Use— Functional performance attributes including mechanical durability and impact resistance

USP <382> — Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems— Fragmentation and puncture‑related functional assessments

ANSI Z97.1 — Safety Glazing Materials Used in Buildings(impact classification reference)

EN 12600:2002 — Glass in building — Pendulum impact testing(falling weight energy reference)

YBB 00212005 / YBB 00222005 (Chinese Pharmacopoeia equivalents)

GB/T 14485‑93 (Historical Chinese national standard, superseded)

Key Features

USP‑Ready Documentation: Automatically calculates impact energy and prints comprehensive reports - including impact value, mean, variance, ball mass/diameter, drop height, and sample thickness - formatted for USP validation dossiers and audit trails.

Electromagnetic Release with Auto‑Centering: The electromagnetic sucker ensures zero initial velocity and no lateral force, guaranteeing a true free‑fall. Automatic center positioning eliminates manual alignment errors.

Pneumatic Specimen Clamping: Consistent, even clamping pressure prevents specimen slippage or pre‑stress, eliminating operator variability and reducing test time.

Automatic Height Positioning: The instrument drives the ball to the preset height with 0.1 mm resolution - no manual ruler measurement required.

High‑Resolution Impact Calculation: Impact energy resolved to 0.001 N·m for precise quantification of subtle material differences.

Built‑in Observation Lamp: Integrated LED illumination provides shadow‑free lighting at the impact zone, enabling clear and accurate judgment of micro‑cracks, star‑shaped fractures, or perforations.

Safety Protection: A steel ball rebound guard prevents operator injury during high‑energy drops.

Multi‑Ball Compatibility: Five standard steel balls (50 g – 550 g) cover a wide range of impact energies for different material thicknesses and specifications.

Technical Specifications

Parameter	Specification
Test Height Range	25 – 900 mm (adjustable)
Height Resolution	0.1 mm
Impact Energy Resolution	0.001 N·m (calculated)
Maximum Specimen Size	150 × 150 mm
Standard Steel Balls	Φ23 mm / 50 g; Φ25 mm / 60 g; Φ28.6 mm / 100 g; Φ38.1 mm / 230 g; Φ50.8 mm / 550 g (optional)
Clamping Mode	Pneumatic
Release Mechanism	Electromagnetic sucker with auto‑centering
Gas Pressure Requirement	0 – 0.7 MPa (user‑supplied)
Gas Connector	Φ6 mm Polyurethane tube
Overall Dimensions	500(L) × 480(B) × 1450(H) mm
Net Weight	84 kg
Power Supply	AC 220/110V, 50/60 Hz

Standard Configuration

Main testing machine (host unit)

Electromagnetic sucker assembly

Pneumatic specimen clamping device

Standard steel balls: Φ23 mm (50 g), Φ25 mm (60 g), Φ28.6 mm (100 g), Φ38.1 mm (230 g)

Built‑in observation lamp

Micro thermal printer

Operation manual and calibration certificate

Application Industries & Scenarios

Pharmaceutical Packaging (Primary)

Aluminum‑Plastic Combination Caps: Impact resistance validation for injection vial caps and infusion bottle closures per USP <382> functional suitability requirements.

PVC / PVDC Rigid Sheets: Blister‑forming hard films — evaluate impact toughness before and after thermoforming for solid oral dosage packaging.

Pharmaceutical Plastic Containers: Drop‑impact screening of HDPE / PP bottles for tablet and capsule packaging.

Medical Device & Diagnostic Packaging

Sterile Barrier Rigid Trays: Impact durability of PETG / PC medical trays used in automated filling and sealing lines.

IV Component Housings: Validate impact resistance of rigid plastic connectors and adaptors.

Security & Safety Glazing (Secondary)

Medical Facility Security Glazing: Impact classification of laminated security windows in hospitals and pharmacies per ANSI Z97.1.

Laboratory Safety Shields: Validate impact resistance of polycarbonate protective barriers.

Third‑Party Testing & CROs

USP Compliance Testing: Issue test reports referencing ASTM D3029 methodology to support USP <661.2> / <382> submissions.

Comparative Material Screening: Benchmark new resin formulations (e.g., high‑impact PP, cyclic olefin copolymer) against existing pharmacopoeia‑qualified materials.

Frequently Asked Questions (FAQ)

Q1: Does this instrument directly "comply with USP"?

A: USP <661.2> and <382> define functional performance expectations for pharmaceutical packaging — they do not prescribe a specific instrument or test method. This LabStone Drop Ball Impact Tester uses ASTM D3029 (the internationally recognized free‑fall weight method) to generate the empirical impact data needed to demonstrate compliance with USP functional requirements. The instrument's automatic calculation, statistical reporting, and printable records are specifically formatted to support USP validation documentation.

Q2: How is this different from a general-purpose drop ball impact tester?

A: While the core free‑fall principle is shared, this model is configured for pharmaceutical rigid packaging applications. It emphasizes ASTM D3029 as the test method and positions results within the USP <661.2> / <382> functional evaluation framework. Additionally, it features automatic energy calculation and statistical report printing - capabilities essential for audit‑ready pharmaceutical QC but often absent in basic general‑purpose models.

Q3: Can I use this for ASTM D3029 testing?

A: Yes. The instrument is fully compatible with ASTM D3029‑21 Method F (free‑fall ball). The height range (25–900 mm), ball masses (50–550 g), and pneumatic clamping meet the standard's requirements for flat rigid plastic specimens.

Q4: How is impact energy calculated?

A: Impact energy (in N·m) = mass of the steel ball (kg) × gravitational acceleration (9.81 m/s²) × drop height (m). The instrument automatically performs this calculation and prints the result along with statistical analysis (mean, variance) — no manual computation required.

Q5: What gas supply is needed?

A: The pneumatic clamp requires a clean, dry compressed air source at 0 – 0.7 MPa. Connection is made via a standard Φ6 mm polyurethane tube. An in‑line filter‑regulator is recommended to protect the pneumatic components.

Q6: Can this test flexible films or only rigid sheets?

A: This instrument is designed for flat, rigid specimens (plastic sheets, plates, caps, and rigid containers). For flexible films, a Free‑Fall Dart (FDD) Tester per ASTM D1709 or ISO 7765 is the appropriate alternative.

Q7: Is the built‑in printer sufficient for GMP records?

A: The micro‑printer provides immediate hard‑copy records with all critical parameters. For full GMP compliance (audit trails, electronic signatures, user access control), we recommend pairing the instrument with our optional professional PC software module, which adds database management and secure report generation.

Function:
Test the performance of plastic sheet against drop ball impact.
Principle:
Electromagnetic sucking test steel ball；The instrument will automatically raise the steel ball to the height required by the test standard；power-off the electromagnet to release the steel ball, and the steel ball falls freely to impact the specimen; observe the specimen damage, calculate the impact energy, and determine the impact resistance of the specimen.
Standards：
GB/T 14485、YBB00212005、YBB00222005、YBB00212005、GN/T15267。
Characteristics：
- Electromagnetic sucking steel ball, automatic center positioning and automatic releasing.
- Specimen pneumatic clamping and releasing.
- The height of the steel ball is automatically determined by the instrument and driven to the position accurately.
- Automatic calculation of drop ball impact resistance of specimen.
- The test data is printed, include Impact value, mean value, variance, ball mass, ball diameter, drop height and sample thickness, and so on.
- Steel ball protection device to avoid personal injury.
- A variety of steel balls can be selected to meet the requirements of various standards.
- The test height can be adjusted according to different standards.
- The built-in observation lamp can judge the impact fracture of the sample more clearly and accurately
Specification
- Test height： 25-900 mm（adjustable）.
- Height resolution：0.1 mm；
- Resolution of impact force：0.001 N^.m；
- Size of specimen： 150Ⅹ150；
- Steel ball diameter： 23 mm；25 mm；28.6 mm；38.1 mm；50.8 mm（optical）；
- Mass of steel ball： 50 g； 60 g； 100 g； 230 g； 550 g（optical）；
- Clamping mode： Pneumatic.
- Hang mode： Electromagnetic sucker.
- Gas pressure： 0-0.7 MPa（Gas source provided by users）.
- Gas connector: Ф6mm Polyurethane pipe.
- Size： 500mm(L)Ⅹ 480mm(B) Ⅹ1450mm(H)；
- Power supply： AC220/110V 50/60Hz；
- Net weight： 84 kg。
Configuration:
Principle machine, Electromagnetic sucker, Specimen pneumatic clamping device.
Steel ball：diameter 23 mm-50 g, diameter 25 mm-60g, diameter 28.6 mm-100 g, diameter 38.1 mm-230 g.

Keywords:

Drop Ball Impact Tester for Plastic Sheets & Rigid Plates

Drop Ball Impact Tester - Bottle Cap