Elga Pharma Compliance

Purelab Pharma Compliance – Bringing Elga’s Ultrapure Water Purification To Gxp Quality Control Laboratories

The ELGA Veolia Purelab Pharma Compliance delivers a lab water solution focused on building the perfect relationship between discovery, production, and traceability, resulting in an intuitive, efficient, and compliant purification system.

Purelab Pharma Compliance is packed with innovative features optimised for QC laboratories. It offers all the necessary purification, software capabilities, qualification documentation, and online support services necessary for the validation required to meet Good Manufacturing Practice (GMP). This includes secure software providing the evidence to meet FDA and EU standards for digital record keeping. Qualification documents provided enable the unit to support labs subject to validation under GxP.

Orion Versastar

The Orion VersaStar meters range of portable and benchtop pH, conductivity, ion selective electrode (ISE), dissolved oxygen, or multiparameter meters can be coupled with the Orion Navigator Pro software. This enables the transfer of measurement and calibration data from your meter to a computer in a few simple steps. Use the meter data log to take measurements when your samples are ready and then transfer measurements to a computer at your convenience. Ensure digital data integrity with password-protection, electronic records and audit trails.

The STAR A Series meters

Thermo Scientific™ Orion™ Star Com™ software makes it easy to transfer data from your meter to a computer and is compatible with Thermo Scientific™ Orion™ Star™ A
and Thermo Scientific™ Orion™ Versa Star™ meters.

Inolab Multi 3620 IDS

Digital measurement with two universal measuring channels with the Multi 3620 IDS – pH, ORP, dissolved oxygen and/or turbidity simultaneously

Novasina Labmaster

(This powerful but under-used quality parameter is gaining interest in the Pharmaceutical Industry with the release of the USP 922 Water Activity method. Both USP 922 and USP 1112 highlight the potential applications for water activity. These include stability control, microbial risk prevention, optimized formulation, reduced caking and clumping, and moisture migration control, which all have significant product improvement advantages. The resulting key benefits are; fewer consumer complaints, greater confidence, higher production output with consequently better products for the consumer, and greater profits for the manufacturer. Conclusively, water activity is a powerful, and often essential, quality parameter for pharmaceutical products.

Ebro

What are the typical features of data loggers?
Data loggers are designed to measure and record specific physical values so they can be transferred to a computer in real-time or after a set interval. The type of measured values determined in this way depends entirely on the sensor of the data logger. Data loggers have different properties depending on the desired application:

Hettcube

With its volumes of 200L, 400L and 600L and a wide range of accessories, the HettCube incubator is well suited for all pharmaceutical, research, and microbiological applications.

These units are also available with refrigeration and a temperature range from 0 °C to +65 °C (HettCube R).

Easy weekly programming with intuitive operation on the new touchscreen
Any event or irregularities such as door openings or power failures are electronically documented in the logbook. Each Hettcube is temperature validated before delivery using a 9-point measurement and receives a Hettcube factory certificate according to DIN 12880: 2007-5
IQ / OQ documentation is available.

Weiss

The Pharma cabinets from Weisstechnik® were specifically developed to meet the requirements of a test laboratory in pharmaceutics. They are robustly constructed and available in four sizes: Pharma 280, Pharma 600, Pharma 1300 and Pharma 2000.

Reliable measurements are ensured by:

• The work area of the cabinets easily complies with the requirements of ICH Q1A Guideline.
• The cabinets also allow tests to be conducted with other specifications in the power range of the systems.
• The temperature and air humidity are controlled by high-precision sensors in conjunction with a specially designed controller.

Miele

Miele’s washer-disinfectors ensure optimum cleaning results and thermal disinfection in compliance with international standard DIN EN ISO 15883.

Miele, the performance leader in glassware washing systems, manufactures a full range of systems that can be validated quickly and easily.

In the pharmaceutical, food, and cosmetics industries, the cleaning systems used in areas of production, quality assurance, and research and development must be qualified.

The IQ/OQ documents (standard documents) are prepared by Miele. Labotec Technical Department have been trained and certified to carry out the qualifications.

The following models are most suitable for the Pharmaceutical Industry:

PG8593 – Lab washers from Miele Professional

PG8593 with complete drying through a class H13/H14 HEPA filter ensures the reliable removal of particles from the air taken in for drying, hygienic chamber, optimised spray arms with spray pressure and spray arm monitoring. The innovative load carrier system – Easy Load, offering greater efficiency, versatility and ease of use.

PG8583CD – Lab washers from Miele Professional

PG8583CD with all of above as well as an integrated dispenser pump for liquid dispensing, drawer for the supply of detergent canisters and conductivity monitoring.

The PLW 7111 SlimLine laboratory washers

The PLW 7111 SlimLine laboratory washers offer a comprehensive and systematic solution for the analytically pure reprocessing of laboratory glassware.

• Smart Load Plus – for flexible use of wash cabinet space
• EasyLoad – systematic efficiency and convenience
• Space-saving SlimLine design
• Freely programmable controls
• Flexible reprocessing of laboratory glassware
• Status display via chamber lighting
• Connectivity-ready

The PLW 7111 series of SlimLine laboratory glasswashers provide performance and user-friendliness. This entirely redesigned washing system boasts considerably better performance compared with the previous series and, thanks to a variable-speed pump, is able to adjust circulation pressure and water consumption to the load in hand.

The high-quality colour touch display in combination with the innovative multi-colour chamber lighting makes for intuitive loading and excellent control over the entire process.

The new EasyLoad system is available on SlimLine models, simplifying loading and supporting users in correctly positioning their items of laboratory glassware. Thanks to the intelligent use of space by the EasyLoad system, the capacity for 100 ml bottles for instance has been increased by more than 50% compared with the previous series.

Forma Thermo Universal Range

The new TSX Universal Series ULT freezers herald a new era in performance with Universal V-Drive technology, delivering tighter control and faster recovery times. This is coupled with an expanded setpoint range, universal voltage, whisper-quiet operation, simplified software updates and much more, to adapt to your workflow. Advancing sustainability, they are ENERGY STAR® certified with a 33% efficiency improvement, ACT labelled, and produced in a Zero-Waste to Landfill certified facility in Asheville, North Carolina.

From sealed system and cabinet construction to software architecture and electrical components, each element of the TSX Universal ULT platform has undergone significant testing and improvements. All of the TSX Universal ULT units undergo a comprehensive end-of-line testing process, which is documented and results in a factory acceptance test report and a certificate of calibration provided with every unit produced.

Liquid handling solutions for pharmaceutical and biotech labs
The pharma industry requires accurate and precise liquid handling solutions for almost every task, including cell culture maintenance and QA/QC testing for pharmaceutical, antibody or vaccine production. User-friendly automation that can be rapidly implemented with minimal training, like INTEGRA’s pipetting robots, help to ensure the quality of the end products. Together with convenient laboratory aids, such as INTEGRA’s pipette controllers and aspiration systems, these solutions help to enhance safety and improve the efficiency, productivity and data security of the lab. Scientists save time and benefit from optimal ergonomics while minimizing the potential for human error and having the flexibility to switch easily from one project to another.

Media Preperation

Viaflo 96/384

The Viaflo 96 | 384 enable transfers of 96 and 384 samples in a single step, thus increasing pipetting throughput and reproducibility significantly.

Viaflo Assist

Automated multi-channel pipetting for the best results and unmatched ergonomics.

Viaflo Assist Plus

Automating routine pipetting tasks, eliminating physical strain and ensuring superior reproducibility and error-free pipetting

Buchi

Melting point analysis can be used to perform quality control on the compound of interest. Determination of the novel compound’s melting point serves as a useful indicator of the material’s purity

IQ/OQ

Melting Point M-565

The Melting Point M-565 for the automatic determination of melting and boiling points is designed for true, professional quality control.

Buchi

KjelMaster K-375; The automatic distillation unit KjelMaster K-375 is designed for convenient nitrogen and protein analysis. The reduced need for user interaction and an intelligent software save time and costs. Automation and throughput are increased significantly by using the KjelSampler K-376 or K-377.

21 CFR Part 11 / Q/OQ

KjelMaster K-375

We provide solutions for both potentiometric and colorimetric titrations.

Buchi

NIR is a fast and safe screening method that provides reliable results within (milli)seconds. The non-destructive technique is applied for raw material identification during incoming inspection as well as for quantification of multiple parameters in intermediate and final products. With NIR Atline and Online solutions, you can ensure your quality, optimize all process steps, and thus improve your productivity and profitability. The laboratory device can moreover be applied to check content uniformity in tablets and capsules. Modular design that meets the highest spectrometer precision.

Identification & Quantification of raw materials, intermediates, and final product.

21 CFR Part 11 / IQ/OQ

NIRFlex N-500

The modular FT-NIR spectrometer

The N-500 FT-NIR spectrometer provides reliable analysis results for quality control as well as research and development in the pharmaceutical, chemical, food, beverage and feed industry. The NIRFlex N-500 offers a wide range of measuring cells and accessories for great flexibility and highest performance.

ANALYSETTE 22 NeXT

The ANALYSETTE 22 NeXT is ideal for particle size analysis in production, quality control, research, development, or manufacturing processes. The Micro model measures from 0.5 to 1500 μm, while the Nano model expands the lower measurement value with an additional detector system. Its modular design allows for flexible growth and the addition of modules as needed, ensuring adaptability to various analytical needs.

ANALYSETTE 28 Image Sizer

The ANALYSETTE 28 Image Sizer is a versatile tool for measuring powders, bulk solids, suspensions, and emulsions. It offers accurate and reproducible results for particle shape and size, with a wide measuring range and multiple shape parameters, making it essential for comprehensive sample analysis.

Vwr

Analysis has been widely used for the identification and investigation of pharmaceutical materials with the VWR Visicope range of microscopes. They enable detailed observations and measurement of the microstructures and the interaction between active pharmaceutical ingredients (API) and inert excipients. With the use of a microscopic aspect ratio to control powder flow characteristics for active pharmaceutical ingredients: Acceptance criteria for API particle size distribution are often required by worldwide regulatory authorities, especially for insoluble drugs. However, API morphology (round vs needle shape), though critical to the manufacturability of the finished product is not usually controlled. The development of an aspect ratio specification using microscopic image analysis is described. This helps downstream process control and content uniformity of solid dosage for manufacture.

Rotavapor® R-300:

Meets the Highest Expectation & Versatility in Rotary Evaporation. Its Modular design allows the R-300 to be fully extended to a fully integrated system where a central interface regulates each component. The search for active pharmaceutical ingredients (APIs) and
chemical compounds typically begins with a synthesis or an extraction step. Reflux synthesis
and Soxhlet extraction can be performed via a rotary evaporator.

IQ/OQ

Rotavapor® R-220 Pro:

Designed to fulfill a wide range of distillation applications in the industrial/ environment. Safety, robustness, and easy handling are the key benefits of this system. Seven different glass configurations and a wide range of accessories guarantee the perfect setup for maximum performance.

IQ/OQ

Universal Extractor E-800

Powerful & Perfect for Multitasking

The UniversalExtractor E-800 is perfectly suited for any demanding extraction task. Six distinct extraction positions enable individual process control and simultaneous operation of different extraction methods. High-speed heaters combined with sophisticated process control allow for the fastest and most reproducible extraction processes.

SpeedExtractor E-914 /E-916

Combine maximum speed and throughput

The SpeedExtractor is your best solution for fast Pressurized Solvent Extraction (PSE). Increase productivity by processing up to 6 samples in parallel. With the ease of sample loading and the ready-to-use extract collection, it’s possible to streamline the workflow of your sample preparation.

Parallel Evaporation:

Syncore plus: Since both synthesis and extraction require large amounts of solvent, a concentration step is required prior to downstream processing. Here, rotary evaporation is used to remove the solvent and concentrate the compound of interest. The use of parallel evaporation can speed up the concentration of multiple samples. Many samples are evaporated simultaneously, which increases sample throughput.

IQ/OQ

Flash Chromatography Prep HPLC

(Pure Instruments & Consumables): Flash and preparative high-pressure liquid chromatography (prep-HPLC) are commonly used to purify target compounds: flash is used as a pre-purification step, whereas prep HPLC increases the purity of the target compound to the maximum.

IQ/OQ

Prep SFC:

Traditionally, SFC was used only for chiral and low-polarity compounds. However, significant advances in instrument performance and column types that recently became possible extend the applications to achiral and more polar compounds. It is now possible for SFC to separate any compound at high purity.

IQ/OQ

Lyovapor From Buchi

Freeze Drying- Lyovapor™: Following the separation process, molecules of interest are highly diluted and must be concentrated before proceeding with the next steps. Freeze drying can be used to remove solvent from heat-sensitive products with minimal damage.

IQ/OQ

Small Batch Benchtop Freeze Drying Production (Telstar)

LyoBeta, LyoAlfa and LyoQuest laboratory freeze dryers from Telstar can deliver precision and reliability in lyophilization. With Telstar, you have a partner dedicated to your success, offering state-of-the-art solutions for the first steps, scale-up, or production of small batches. Designed according to GLP principles to comply with the strictest international standards, the laboratory freeze dryer range covers small tabletop units to sophisticated pilot equipment. Please do not hesitate to contact us for advice on process development.

Spray Drying S-300

For more than 40 years BUCHI has been developing market-leading solutions for laboratory spray drying and encapsulation. Active pharmaceutical ingredients, drug delivery, vaccines, inhalable drugs, taste masking. Methods include Drying, Amorphous solid dispersions, encapsulation of liquids, and Encapsulation of solids.

IQ/OQ

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