Pharmceutical analysis at WESSLING
Our GMP-certified laboratory in Münster is a partner for pharmaceutical companies, manufacturers of active ingredients, excipients and ready-to-use pharmaceuticals, and hospital pharmacies. Our customers also come from the fields of cosmetics, medical products and dietary supplements.
Our laboratory in Münster, also inspected by the FDA (U.S. Food and Drug Administration) with a total area of about 1500 sqm, provides you with complete solutions for microbiological and chemical-physical tests.
We provide our customers with fast, professional and reliable services in the field of microbiological and chemical-physical quality control, including stability storage and testing of pharmaceuticals and medical products. Under GMP conditions, we examine pharmaceutical raw materials and ready-to-use pharmaceuticals in all dosage forms (solid, semi-solid and liquid forms).
All activities in our Pharmaceuticals division - analyses, method development and project implementation - are carried out in accordance with the EU-GMP guidelines and in compliance with cGMP. In addition, around twenty annual customer-based audits at the Münster location ensure the quality and worldwide acceptance of our services. In addition, the laboratory location in Münster has a manufacturing permit in accordance with §13 AMG (German Medicines Act).
Our services in detail
Our services in detail
Microbiological tests of sterile pharmaceutical products
Microbiological tests of sterile pharmaceutical products
The pharmaceutical experts at WESSLING conduct microbiological tests of sterile products according to international pharmacopoeias and to current DIN EN ISO procedures.
Our range of services
Test for sterility using two insulators according to Ph. Eur. 2.6.1
- Membrane filtration method
- Direct feeding method
- Testing with special test systems
- Testing of large-volume samples
- Media additives
- Subsequent growth control, per germ
- Identification of germs with positive results
- Testing of cytostatic agents
- Transmission of intermediate results
Validation of sterility testing
- Preparation of a validation plan/report
- Validation according to Ph. Eur. with 6 test germs
- Method devlopment
Endotoxin tests according to Ph. Eur. 2.6.14
- By Limulus amoebocyte test (LAL test)
- Gel formation limit value method / gel clot (method A, limit test)
- Kinetic turbidimetric method (Method C, quantitative determination)
Endotoxin tests according to Ph. Eur. 2.6.32
- By rFC test (recombinant factor C test): preserves the natural occurrence of horseshoe crab, since no lysate is used
Our services in detail
Microbiological testing of non-sterile pharmaceutical products
Microbiological testing of non-sterile pharmaceutical products
In the microbiological analysis of non-sterile products, our experts proceed in accordance with national and international pharmacopoeias and also with current DIN EN ISO procedures. In addition, we check all procedures for suitability and their validation.
Our range of services
Determination of bacterial count (bioburden) according to Ph. Eur. 2.6.12
- Total aerobic microbial count (TAMC)
- Total combined yeasts/mould count (TYMC)
Detection of specified microorganisms according to Ph. Eur. 2.6.13
- Quantitative and qualitative detection
Testing for adequate preservation (KBT) according to Ph. Eur. 5.1.3
Combined tests for ready-to-use pharmaceuticals according to Ph. Eur. 5.1.4
Combined tests of herbal medicinal products for oral use according to Ph. Eur. 5.1.8 according to categories A, B, C
Microbiological hygiene monitoring and particle monitoring
- Sampling by qualified WESSLING employees on request
- Provision of contact plates, air sampler and particle measuring device
- Evaluation of contact plates: aerobic bacterial count, yeasts / moulds, enterobacteriaceae
- Surface inspection by means of swabs
- Airborne germ measurements: germ count and moulds
- Particle measurements
Microbiological determination of the value of antimicrobial agents (e.g. neomycin, gentamycin)
Identification of germs
- Biochemical identification of germs using API
- Using Maldi-TOF/MS
- Creation of house germ databases
Our services in detail
Chemical-physical tests for pharmaceuticals
Chemical-physical tests for pharmaceuticals
Our range of analyses covers the entire spectrum of chemical-physical tests of pharmaceutical products. In addition to conducting standardised analysis procedures, our experts also provide the development and validation of procedures for customer-specific requests.
Our range of services
Testing of raw materials, ancillary and active substances according to international pharmacopoeias
- Identification and determination of APIs and ingredients
- Quality control of raw materials
- Tests for identity, content and purity according to current national and international monographs or customer regulations (Ph. Eur, USP, JP, RuP, ChP, etc.)
Release tests
EU-Batch Release Service, including batch release by WESSLING-QP
Stability tests
We conduct long-term, short-term and in-use stability tests on ready-to-use pharmaceuticals, medical products containing pharmaceutical ingredients and active ingredients in accordance with current ICH and GMP specifications. The test includes the parameters relevant for stability, such as content, purity and active substance release.
Our service includes the development of test plans, overview tables for stability tests and individual stability reports.
Storage without commissioning analytical tests is also possible.
We can offer you the following climatic conditions:
- 25°C/60% rel. humidity
- 30°C/75% rel. humidity
- 40°C/75% rel. humidity
- Photo stabilities
- Subtropical and tropical conditions on request
Method development, -transfer and -validation
Our pharmaceutical experts at WESSLING develop and validate methods under GMP on behalf of customers. The suitability and thus the validity of all test methods used must be proven during the approval and registration of medicinal products.
In addition, for food and dietary supplements we provide adapted validations based on pharmaceutical validation.
- Development of new and optimisation of existing methods
- Validiation in compliance with ICH guidelines
- Preparation of validation plans
- Preparation of validation protocols and non-confomrance reports
- Preparation of final validation reports
- Method transfer
- Development of test regulations
Elemental impurities - ICH Q3D
The experts for pharmaceutical analysis competently support their customers in implementing the ICH Q3D Guideline, evaluating their active ingredients, reagents, starting materials and excipients and preparing risk analyses.
The elements are determined in our GMP laboratories using ICP-MS and ICP-OES devices.
These techniques have now found their way into international pharmacopoeias. In the European Pharmacopoeia they are listed in chapters 2.2.58 and 2.2.57, in the USP in chapter '233'. Both methods are characterised by the highest selectivity and lowest detection limits.
Our experts at WESSLING are also happy to conduct the product-specific validation of the methods according to the ICH Q2B Guideline.
Our services in detail
Method overview
Method overview
Our state-of-the-art equipment and knowledge of our experts at both locations in Münster and Budapest characterise the pharmaceutical analysis of the WESSLING Group.
General methods
- Laser diffractometry, EP 2.9.31: determination of particle size
- IR-microscopy (transmission / reflection / ATR): testing for drug authenticity / drug counterfeits, analysis of film thickness
- Characterisation of nanomaterials in ready-to-use medicinal products
- Spectroscopy / spectrometry: IR spectroscopy, UV-VIs spectroscopy, mass spectrometry, mass spectrometry with inductively coupled plasma (ICP-MS/OES)
- Thin layer chromatography: identity testing, semiquantitative purity tests, quantitative purity tests, content determinations
- Gas chromatography (GC, GC-MS): content determination / determination of RLM, identity checks, detectors: DAD, MS, TCD, feed systems: head space and split / splitless
- Liquid chromatography (HPLC, HPLC-MS): content determination, testing for related substances, identity checks, detectors: fluorescence, DAD, UV/Vis, MS, RI
- Sterility tests using two isolators
- Endotoxin determinations, method A and C
- Test for absence of THC
- Paper chromatography
- Determination of total organic carbon (TOC)
- Clarity and opalescence of liquids
- Colouring of liquids
- Conductivity
- pH value: potentiometric method, indicator method
- Relative density
- Drying loss
- Potentiometric titration
- Optical rotation
- Viscosity (rotational viscometry)
- Brookfield viscosity
- Refractive index
- Melting temperature
- Boiling temperature
- Distillation area
Identity testing of pharmaceuticals
- Ions and functional groups
- Fatty oils by thin-layer chromatography
- Phenothiazines by thin layer chromatography
Limit tests for pharmaceuticals
- Ammonium
- Arsenic
- Calcium
- Chloride
- Magnesium
- Heavy metals
- Iron
- Phosphate
- Potassium
- Sulfate
- Ash/sulphated ash
- Free formaldehyde
- Alkaline reacting substances in fatty oils
- Determination of metal residues
- Testing of fatty oils for foreign oils by thin layer chromatography
- Fatty acid composition
- Sterols in fatty oils
- Determination of solvent residues
Determination of the content of pharmaceuticals
- Acid value
- Ester value
- Hydroxyl number
- Iodine number
- Peroxide number
- Saponification number
- unsaponifiable parts
- Complexometric titration
- Karl Fischer method
- Phenol in sera and vaccines
- Protein in polysaccharide vaccines
- Nucleic acids in polysaccharide vaccines
- Phosphorus in polysaccharide vaccines
- Protein content
Methods of pharmacognosy
- Ash insoluble in hydrochloric acid
- Foreign components
- Stomata Index
- Source number
- Pesticides
- Determination of tannin content in herbal drugs
- Bitter value
- Dry residue and drying loss of extracts
- Aflatoxins B1 in herbal drugs
- Analysis for aistolochic acids in herbal drugs
- Ochratoxin in herbal drugs
- Microscopic examination of herbal drugs
Methods of pharmaceutical technology
- Decay time of tablets and capsules
- Decay time of suppositories and vaginal suppositories
- Drug release from solid dosage forms by dissolution tester (on-/offline)[Paddle and Basket]
- Compilation of release profiles (PMP/EWP/QWP/1401/98), compilation of bioequivalence studies, biowaver
- Friability (abrasion)
- Tablet hardness
- Uniformity of content and mass of single-dose dosage forms
- Visible particles
- Particle size distribution
- Particle contamination - invisible particles
- Determination of the extractable volume of parenteralia
- Ethanol content
- Methanol and 2-propanol
- Microscopy
Our services in detail
Laboratories and equipment
Laboratories and equipment
GMP-certified pharmaceutical laboratory site in Münster
At WESSLING, the thrust of our analysis and consulting for pharmaceuticals and medical products along with our service portfolio is international. WESSLING is therefore also a partner to pharmaceutical manufactures whose markets lie outside of Europe:
- The laboratory in Münster works according to GMP standards
- Our pharmaceutical site holds a manufacturing permit according to Section 13 of the German Pharmaceuticals Act (AMG) and an EU import permit
- Our pharmaceutical laboratory in Münster is inspected by the FDA (Food and Drug Administration). As a result, we are also an analysis partner to customers who are operating in the US market
- The close cooperation between our experts means combined capacities and know-how for our customers, resulting in on-time processing - even of larger orders or those for express analysis
One-stop shop: from us, manufacturers of pharmaceuticals and medical products obtain all laboratory analyses from a single source: microbiology, chemistry and consulting. Thanks to the close integration of our laboratory analysis and consulting, WESSLING is your full-service provider:
Analysis:
- Testing of all dosage forms: testing of sterile and non-sterile solid, semi-solid and liquid pharmaceuticals
- Testing of cytostatic drugs and permit for handling narcotic drugs according to Section 3 of the German Narcotic Drugs Act (BtMG)
- Sterility tests using two isolators: redundancy minimises the risk of failure and thus guarantees that your orders are processed on time
- Determination of elementary contamination by means of ICP-MS/OES
Special analysis:
- Wealth of experience and know-how in developing and validating analytical methods (HPLC, dissolution, GC)
- Approval analyses with subsequent market release by experienced WESSLING QPs (Qualified Person) and logistics solutions
- Close integration of analysis and consulting
70 experts in Münster work with the latest technical equipment in equally cutting-edge, generously sized facilities; our laboratory covers a total floor space of around 1500 square metres
Our pharmaceutical analysis equipment:
- Approximately 8 HPLCs with UV/VIS, DAD, fluorescence, RI or MS detector
- 1 uHPLCs
- 3 gas chromatographs with head space and trap unit, FID or MS detector
- ICP-MS and ICP-OES
- 2 dissolution testers (UV on-/off-line), paddle and basket
- 2 disintegrators
- FT-IR spectometry with ATR unit
- UV/VIS spectometry
- Polarimetry
- Density measuring unit
- Automatic titration unit
- TOC
- Particle size distribution (Malvern)
- 2 endotoxin readers: fluorescence and recombinant measurement
- 2 sterile test isolators with fast-action sluices
Interdisciplinary and international
With over 70 highly qualified employees in Münster, we support the pharmaceutical industry and hospital pharmacies in the development, quality control, stability storage, and testing of pharmaceuticals and medical products. Through this interdisciplinary and international cooperation we are able to provide our services particularly for microbiological and chemical-physical testing quickly at the highest level.
Our experts provide pharmaceutical quality control as a full service, including batch certification and approval through our QPs. The experts at WESSLING are also experienced in dealing with cytostatics and narcotics. As GMP-certified testing laboratories, we continue to be subject to constant monitoring by the responsible authorities.
In addition, the laboratory has a manufacturing permit in accordance with §13 AMG. Our laboratory has an EU import permit for pharmaceuticals from non-EU countries. This enables us to carry out release tests with QP certification for our partners (EU batch release service). Furthermore, we are licensed to handle narcotics according to § 3 of the German Narcotics Act (BtMG), e.g. for quality control testing of cannabis products.
Your contact for pharmaceutical analysis
- Dr. Maik Siebelmann
- +49 251 13 39 880
- pharma@wessling.de
„To protect consumers, pharmaceutical products require particularly thorough quality control. In our GMP-certified laboratory in Münster we provide comprehensive service for all aspects of quality control and approval.“
