Pharma Technology

Klarwin Pharma Technology offers complex solutions for processing of pharmaceutical fluids, particularly sterile, but also optimization and/or full contamination control of the existing processes, according to the latest GMP requirements.

Based on long-term partnerships with word-wide technological leaders in the field of pharmaceutical equipment and installations, Klarwin has been developing, together with its Romanian customers, technological solutions for safe processing of pharmaceutical fluids.

Klarwin’s consulting services will help you make the best decision in dimensioning, operating and optimizing the necessary installations and produce, for the most attractive cost, sterile and non-sterile pharmaceutical products for human and veterinary use, in liquid, solid, semisolid, or aerosol forms.

Sterile liquid products for human use
Non-sterile liquid products for internal or external use
Sterile solid products
Non-sterile solid products
Non-sterile pressurized products
Non-sterile semisolid products

World leading technological partners

Safe technologies, according to GMP and USP requirements

Specialized training module for pharmaceutical processes

We innovate solutions for process safety

Filtration, separation and purifications of pharmaceutical products

Pharmaceutical producers of sterile products for human and veterinary use can count on Klarwin to provide state-of-the-art technologies for filtration, separation and purification of their fluids. An adequate risk management allows total contamination control throughout the processing of sterile or non-sterile drugs, that complies with the latest requirements of USP, BP, Romanian Pharmacopoeia, EP, FDA, ANMDM, EMEA, Annex 1 and Annex 15 from GMP etc.

Contamination control solutions for pharmaceutical fluids

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Filter Integrity Test Instruments

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Services for filter integrity testers

Klarwin® provides the following types of services for integrity testers for sterilizing filter media:

On-site commissioning and training;

Annual calibration services with the help of a PALL specialist;

Repair services;

Spare parts during the warranty and post-warranty period;

Tester upgrades.

Calibration and recalibration services for the Palltronic or AquaWIT are performed on a yearly basis, for all testers sold to Romanian customers, during an organized meeting at Klarwin headquarter.

Validation services for sterile filtration

Validation services are performed directly in the specialized PALL laboratories. The validation package includes all types of tests, such as:

Evaluation of the quantity of adsorbed substances in the filter media;

Chemical compatibility of the solution with the filter media used;

Bacterial viability;

Filtrate sterility study after challenging the filter element with a standard microorganism solution or a solution specific to customer’s installation;

Extractables studies from filter elements used by clients;

Leachables;

Generating filter integrity testing parameters after wetting it with the product solution.

Pharmaceutical fluids processing

Klarwin can offer consultancy on installation and design of sterile pharmaceutical product processing, based on customer-specific application technical data. The steps are described below:

1. Conceptual and basic design
2. Detailed design including detailed specifications, as well as work and installation plans.
3. Equipment manufacturing, using GMP-compliant materials and according to USP, EPh, FDA etc. requirements.
4. Installation/equipment assembly and on-site testing
5. On-site equipment / systems assembling and working parameters check
6. Commissioning
7. Validation of equipment / installations by the customer
8. Service & support

Solutions for pharmaceutical fluids processing

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Autoclave solutions

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Testing and qualification of production process and finished form product in primary containers

Klarwin offers services for testing and qualification of production processes and finished products in primary packaging, as required by GMP, such as:

Extractables studies for the sterile products in primary packaging or for standard fluids, according to USP <1663>;

Simulation studies to determine the chemical additives, monomers, oligocenters and substances migrating from the materials that come in contact with the product during the production process;

Studies to determine the quantity of leachables from primary packaging of sterile products, according to USP <1664>. These can be achieved during stability or accelerated stability studies.

Studies that evaluate USP <1660> glass container for glass-released compounds in the final product during storage (delamination studies, determination of extracts that migrate as visible or invisible particles);

Antimicrobial effectiveness testing of products packaged in multidose containers in accordance with USP <51>; The requirements of the method may include species of standard microorganisms and / or species originating from the customer's production area;

Permitted Daily Exposure (PDE) determination according to the latest EU GMP requirements Annex 15.

Validation services for utilities

Klarwin offers validation and revalidation services for production or pilot equipment, as well as for pharmaceutical industry utilities. They are involved in the production of pharmaceuticals and end products in various forms (eg. parenteral products, topical or oral use).The critical utilities that can be validated / revalidated are:

Pure steam production and distribution;

Installations for the production and distribution of pure water and / or water for injectables;

Air treatment installations (HVAC) and contamination-controlled rooms (clean rooms of different classes) including Laminar Air-Flow (LAF) units according to ISO-14644;

Installations for the production and distribution of gases, like compressed air or nitrogen, that comes in contact with the product.

Macroscopic control and/or the leak control of primary packaging of pharmaceutical products

Various solutions for process guarantee

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Pharmaceutical products traceability

All pharmaceutical products producers can benefit from innovative Track &Trace systems for serialization, aggregation, and traceability of all packaged products until they leave pharmacies towards patients or from warehouses towards hospitals.

Various solutions for the traceability of your products

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Training programs and consultancy programs

Based upon a strong collaboration with different pharmaceutical companies, Klarwin organizes training programs and technical assistance related to:

– General GMP topics for specialists involved in the production process (Basic Training on GMP, GMP – General topics, Validation Life Cycle from DQ to PV, Quality Risk Management, Data Integrity);
– Training of the specialists that make technical specifications for purchasing of the required systems and installations (URS);
– Training of specialists involved in the validation of HVAC systems;
– Training courses for specialists involved in the validation of systems that produce purified water, water for injections, steam and process gases;
– Training of specialists involved in the validation of equipment and systems used in wet and dry sterilization;
– Process & product validation – sterile filtration validation;
– Process & product validation – validation and qualification of “single use” systems;
– Process & product validation – primary packaging validation
– Training of specialists for process & product validation – cleanliness validation.

GMP training programs

Klarwin® offers a wide training program at customers’ site or online, either for the operators, engineers or pharmacists who work in pharma industry, regarding:

``In place`` and in the autoclave handling and sterilization of filter elements;

Handling of depth filter plates;

Fundamental principles of filtration;

Validation of sterile filtration according to the latest requirements of the PDA Technical Report 26;

Integrity testing for hydrophilic filter media;

Integrity testing for hydrophobic filter media;

Basic principles of SIP;

Qualification of a filtration system used for sterile filtration;

Basic principles of sterilization by autoclaving;

Developing and validating a pilot production process at industrial level to produce sterile and non-sterile products;

Validation and revalidation of laboratory equipment;

Validation of the cleanliness of equipment used to produce sterile and non-sterile drugs;

Product validation;

Validation of ``single use`` systems used to produce sterile products, processed in aseptic conditions;

Optimization of tangential filtration parameters;

Success stories

Optimization of filtration rating

Upgrade to Ultipleat design

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