Particle Analyzer and Counter - HIAC 9703+

HIAC 9703+ Liquid Particle Counter: Pharmaceutical Quality Control

The HIAC 9703+ liquid particle counter is a benchmark in pharmaceutical research and quality control applications, meeting the rigorous standards of USP <788> (United States Pharmacopeia) .  This equipment was developed to meet the specific needs of liquid particle counting, especially in parenteral solutions , standing out for its high configurability and ease of use.

Features of the HIAC 9703+ Liquid Particle Counter

Execution with Small Samples

One of the main advantages of the HIAC 9703+ particle counter is its ability to perform complete tests with just 1 mL of product. This is essential for preserving valuable samples, especially in research where the amount of available material is limited.

Sample Volume Management

The HIAC 9703+ particle counter handles a wide range of sample volumes, from 1 mL to over 1000 mL. It is pre-configured to ensure that all your application needs are met by pharmaceutical standards. 

Compliance with Pharmaceutical Standards 

USP: United States Pharmacopeia:

The USP is a United States pharmacopoeia that defines quality standards for drugs, foods, and pharmaceutical ingredients. It provides information on composition, dosage, and quality tests, serving as an important reference for the regulation of drugs and substances in the USA.

EP: European Pharmacopoeia:

The EP is the European pharmacopoeia, which defines standards and specifications for medicines in Europe. It is used by all member countries of the Council of Europe, and its norms apply to both medicines produced in Europe and those imported.

JP: Japanese Pharmacopoeia:

The JP is the pharmacopoeia of Japan, which contains quality specifications for drugs, pharmaceutical substances, and their excipients used in Japan. It is regulated by the Japanese Ministry of Health, Labour and Welfare.

KP: Korean Pharmacopoeia:

The KP is the pharmacopoeia of South Korea, which establishes standards for medicines and pharmaceutical products in the country. It is used to ensure the quality and safety of drugs manufactured and marketed in Korea.

Elimination of Data Uncertainty

To ensure the accuracy of results, the HIAC 9703+ particle counter has an alarm notification system that warns of bubbles or sensor contamination, which can impact particle counting. This feature is crucial for maintaining data integrity.

Data Recovery

The HIAC 9703+ particle counter also has a data recovery feature that protects results in case of interruption or power loss. Automatic backup of the database to a secure network location via the PharmSpec software ensures no important data is lost.

Configurability and Flexibility

Interchangeable Flow Rates and Sensors

The HIAC 9703+ offers maximum flexibility by allowing the selection of preferred flow rates and the use of interchangeable sensors with particle size detection ranging from 0.5 to 600 μm. This customization capability is fundamental for meeting different testing needs.

Downtime Reduction

To avoid expensive downtime, the HIAC 9703+ particle counter offers on-site service, eliminating the need to transport the unit for maintenance. Additionally, automated notifications alert when the unit requires routine service, ensuring the equipment is always in perfect working condition.

Safe Sample Handling

The small vial support of the HIAC 9703+ particle counter ensures no valuable sample is wasted, providing security and efficiency in sample handling.

Instrument Validation Services

SOP Assistance and IQ/OQ Validation Services

The validation services for the HIAC 9703+ include Standard Operating Procedure (SOP) assistance and Installation Qualification (IQ) and Operational Qualification (OQ) validation services. These services are essential to ensure the system is commissioned according to operational requirements, ensuring compliance and accuracy of results.

Quality Control with the HIAC 9703+

Importance of Quality Control in the Pharmaceutical Industry

Quality control is a critical aspect of the pharmaceutical industry. It ensures products are safe for use and meet regulatory standards. The HIAC 9703+ plays a vital role in this process, providing accurate and reliable data for liquid particle analysis.

Compliance with USP <788>

Compliance with USP <788> is essential to ensure the safety and efficacy of pharmaceutical products. The HIAC 9703+ is designed to meet these rigorous requirements, facilitating quality control and ensuring products comply with regulatory standards.

PharmSpec Software and Data Security

The PharmSpec software for the HIAC 9703+ facilitates data management and ensures security in 21 CFR Part 11 compliant environments. This software is easy to use and offers advanced features for the efficient and secure management of particle count data.

Benefits of the HIAC 9703+ in Quality Control

Accuracy and Reliability

The accuracy and reliability of the data provided by the HIAC 9703+ are essential for quality control. This equipment eliminates data uncertainty, ensuring consistent and precise results.

Flexibility and Configurability

The flexibility and configurability of the HIAC 9703+ particle counter allow it to be adapted to the specific needs of different quality control applications. This includes the ability to handle a wide range of sample volumes and the use of interchangeable sensors for different particle sizes.

Loss Reduction and Operational Efficiency

The small vial support and data recovery feature of the HIAC 9703+ particle counter reduce sample losses and increase operational efficiency, ensuring tests are performed effectively and without interruptions.

Implementation of the HIAC 9703+ in Quality Control

Implementation Steps

Needs Assessment

The first step in implementing the HIAC 9703+ particle counter in quality control is to assess the specific application needs. This includes determining the sample volumes to be tested and the particle sizes that need to be detected.

Equipment Configuration

Based on the needs assessment, the HIAC 9703+ particle counter can be configured to meet the desired specifications. This includes selecting flow rates and choosing appropriate interchangeable sensors.

Training and Validation

The quality control team must receive proper training to operate the HIAC 9703+ particle counter efficiently. Additionally, IQ/OQ validation services should be performed to ensure the equipment is functioning according to operational requirements.

Benefits of Implementation

Improved Testing Accuracy

Implementing the HIAC 9703+ in quality control significantly improves testing accuracy, ensuring particle count data is precise and reliable.

Increased Operational Efficiency

The flexibility and configurability of the HIAC 9703+ allow for greater operational efficiency, reducing downtime and ensuring tests are performed continuously and without interruption.

Compliance with Regulatory Standards

The HIAC 9703+ ensures compliance with regulatory standards, including USP <788> and 21 CFR Part 11, providing confidence that pharmaceutical products meet safety and efficacy requirements.

HIAC 9703+ Particle Counter Specifications

The HIAC 9703+ is designed to meet a variety of needs in quality control environments. Below are the technical specifications that ensure its efficiency and reliability under different operating conditions:

Specification	Sampler 9703+
Temperature Range	5 to 40°C (40 to 104°F)
Humidity Range	0 to 80% relative humidity, non-condensing
Sample Temperature Range	5 to 40°C (40 to 104°F)
Viscosity Limit	<50 cP
Power Requirement	100/230 VAC, 50/60 Hz
Maximum Power	67 W at 115/230 VAC
Dimensions	343 L X 337 W X 482 H mm (13.5 X 13.3 X 19.0 inches)
Weight	10.7 kg (23.6 lbs)
Sample Vial Free Height	153 mm (6.02 inches)
Volume Accuracy	> 95%
Flow Rate Accuracy	> 95%
Sample Flow Rate	10 to 100 ml/min; The actual flow rate for the system is determined by the sensor flow rate with step-by-step instructions and Pass/Fail results.
Probe Tare Volumes	0.091 ml for 81 L X 1.2 ID mm (3.2 X 0.047 inches) 0.172 ml for 154 L X 1.2 ID mm (6.1 X 0.047 inches) 1.57 ml for 140 L X 6.35 ID mm (5.5 X 0.25 inches) - large diameter

Sensor Range and Compliance Certifications

The HIAC 9703+ is equipped with high-precision sensors and meets important compliance certifications, ensuring equipment quality and safety. See details below:

Sensor	Range
HRLD-150	1.3 μm to 150 μm
HRLD-150JA	1.3 μm to 150 μm (chemical compatibility)
HRLD-400	2 μm to 400 μm
HRLD-600JS	2 μm to 600 μm (chemical compatibility)
Compliance Certifications	CE: Compliance with EMC and Low Voltage Directives Laser Class 1 Product: Complies with IEC/EN 60825-1 and 21 CFR 1040.10 according to Laser Notice 50** ** Contact the manufacturer for complete details on compliance.

Conclusion

The HIAC 9703+ liquid particle counter is an indispensable tool for quality control in the pharmaceutical industry. Its high configurability, accuracy, and reliability make it the ideal choice for research and quality control applications. The PharmSpec software facilitates data management and ensures compliance with regulatory standards, making the HIAC 9703+ a complete and efficient solution for liquid particle counting. With its ability to perform tests with small samples and its flexibility in handling different sample volumes, the HIAC 9703+ is essential for ensuring the quality and safety of pharmaceutical products.