What address can the samples be sent to?
Samples can be sent directly to the following address:
INTERLABOR BELP AG, Aemmenmattstrasse 16, 3123 Belp, Switzerland. It is not necessary to specify a contact person within our company.
Which documents should be enclosed together with the sample shipment?
Each sample consignment should include a fully completed order form and, if available, the pre-established quotation or reference to the quotation number. In addition, the Material Safety Data Sheet (MSDS) should be included if possible, as well as other instructions for correct and safe handling and product storage.
Can samples also be brought in person?
You are welcome to bring the samples personally during our opening hours: Monday to Friday: 07:30 - 12:00 and 13:30 - 17:00.
What is the difference between a sample and a specimen at INTERLABOR?
An analytical sample is a product/material to be analysed or a raw material/auxiliary material/active substance. A sample may consist of several containers or specimens, which are distributed among the different laboratories at INTERLABOR. For example, one specimen may be intended for microbiological testing and another for physical and chemical testing. Nevertheless, these are two specimens of the same analytical sample.
Until when can samples be submitted for microbiological examination?
Samples for microbiological testing should be delivered by 3 p.m. at the latest. Please also note the general opening hours: Monday to Friday 07:30 - 12:00 and 13:30 - 17:00.
Dr. Olivier Aebischer
Head of Customer Service
Dr. Simone Szymanski
In which containers should water samples be delivered for TOC analysis?
100ml glass bottles with PTFE caps are best suited for TOC analysis. We would be pleased to provide you with the appropriate bottles.
What aspects should be considered when packaging/sending food samples for pesticide analysis?
Care should be taken that the samples are not packed completely airtight, as this accelerates the rotting process. Different samples, for example different types of fruit, should be packed separately. Furthermore, the samples should not come into contact with printed materials, as some pesticides may also be contained in printing inks. Attention must be paid to fast delivery. Perishable food should not be sent over the weekend.
What aspects should be considered when packaging/sending herbal drugs for pesticide analysis?
Plastic flu bags are best suitable for dried herbal drugs. In the case of fresh herbal drugs, care should be taken that the samples are not packed completely airtight, as this accelerates the rotting process. Furthermore, the samples should not come into contact with printed materials, as some pesticides may also be contained in printing inks.
What aspects should be considered when packaging/sending samples for pesticide and/or mycotoxin analysis?
When analysing pesticides and mycotoxins, it is important to ensure a representative sample quantity. The issue being, that often, there is no homogeneous distribution of residues within a batch of fruit and vegetables. The EC Directive 2002/63/EC is recommended for guidance for the compilation of a representative sample quantity.
Which sample containers are most suitable for food and water samples in relation to microbiological testing?
To perform microbiological tests, food and water samples should ideally be packed in sterile, tightly sealed plastic containers. The packaging size should be selected so that the sample containers are well but not completely filled. Attention must be paid to fast delivery. Perishable food should not be sent over the weekend.
Which packaging is best suited for samples to be tested for endotoxins?
Care must be taken to ensure that the packaging itself is free of endotoxins. Therefore, sample vessels made of polypropylene must not be used. Vessels made of other plastics or glass are ideal.
Which containers are suitable for sterilizer water, for testing according to DIN EN 285 Steam Condensate B.2 and DIN EN 285 Feed Water B.1?
INTERLABOR provides suitable plastic vessels, free of charge. A sample volume of 1000 mL is required for the analysis.
Dr. Olivier Aebischer
Head of Customer Service
Dr. Simone Szymanski
What are the differences between the analysis qualities "state of the art", "ISO 17025" and "GMP"?
The basis of all analyses are competent analysts and suitable analytical equipment. The three analysis qualities ultimately differ in the validation status of the respective analysis and the internal processes that are applied. The following diagram gives a rough overview over the differences between the three analysis qualities. It can be seen that the process requirements are constantly increasing from "state of the art" via "ISO 17025" to "GMP" and are becoming more product-specific
|ISO 17025|| |
|State of the art|| |
Which process is used at INTERLABOR in case of an OOS result?
Within the scope of GMP, the OOS process comes into play if the result is outside of the specification. This process consists of two phases: Phase 1 is the investigation of an apparent laboratory error and phase II extends the investigation to the product. The latter takes place on behalf of the customer. This procedure is based on the FDA guidelines for handling OOS results ("FDA Guidance for Industry: Investigating Out of Specification (OOS) results for Pharmaceutical Production").
How are OOS results reported?
OOS results are highlighted on the test report or CoA and refer to the corresponding test report. The test report is to be found as a supplement.
What is meant by CAPA?
CAPA is a quality assurance system within the framework of the quality management programme. The focus of CAPAs is on the systematic investigation of discrepancies and the attempt to prevent their recurrence (corrective action) or a possible occurrence in advance (preventive action). Causes of CAPAs can be deviations, observations from audits, customer feedback, OOS results and other sources.
Who is my contact person in case I want to draw up a quality agreement with INTERLABOR?
You are welcome to contact the customer advisor or the quality assurance department.
What is a quality agreement and what information is contained in this agreement?
A quality agreement (QA) is a quality assurance agreement that defines the quality-related responsibilities between the client and contractor. The product-specific specifications and test methods are part of the QA as appendix. This is mandatory for GMP analyses
Dr. Olivier Aebischer
Head of Customer Service
What points should be considered when planing a cleaning validation?
When planning a cleaning validation, one should first consider the sampling procedure (swabbing, extraction, etc.), the type of analytes (specific (lead substances) or non-specific (e.g. TOC)) and the specifications to be applied. The most important aspects are summarized in the following scheme:
Do you offer a screening for lubricants & mineral oil traces for medical devices?
The following procedure is recommended in order to get a first indication of whether contamination by lubricants and mineral oils is present. First step is the performance of an aqueous extraction of the medical device and subsequent TOC analysis. The TOC measurement allows the determination of the total organic carbon. When determining in water samples, the TOC measurement includes both dissolved and undissolved organic constituents. Substances that are detected in the conventional determination of TOC include sugar, mercaptans, oils, cellulose, polyethylene, but also inorganic compounds such as cyanides, carbides and graphite. If the detection of specific organic substances, e.g. certain operating resources, is desired, this is also possible. In this case it is necessary to provide a sample of the corresponding operating resources as a reference. As a rule, mass spectrometry methods can be used to detect traces of the corresponding substance on the product.
What limit values do you recommend for the endotoxin testing of medical devices?
For the definition of the specifications please refer to the USP chapter <161> "Medical Devices-Bacterial Endotoxin and Pyrogen Tests". The relevant document recommends a limit value of maximum 20 IU per object for endotoxins.
Particularly in the case of unprocessed plant raw materials, where no basic homogenization has been carried out, the procedure for compiling a representative sample quantity should be analogous to the requirements of the food regulations (recommended reading: Guidelines for sampling and residue analysis of organic food; Bernhard Speiser, Research Institute of Organic Agriculture (FiBL), CH-Frick (2013)). Regulation (EC) No 401/2006 Methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs.
In addition to the guidelines from the food sector, the general USP chapter <561> "articles of botanical origin" is recommended as a basis of orientation for sampling. The general monograph 07/2007:1433 "herbal drugs" is also recommended.
Particularly in the case of storage toxins such as ochratoxin A or aflatoxins, which may be present in high local concentrations in so-called nests, the composition of a representative sample is an important factor with regard to the significance of analysis results.
What is the minimum sample size required for the determination of cannabinoids in hemp herb or hemp extracts?
In general, a minimum sample size of 5 g is required for plant material. For extracts and oils 1 g is usually sufficient. Since the plant material is ground with a cryo-mill during sample preparation, a larger sample quantity than in the case of extract is required.
What are the advantages of the separate determination of an individual pesticide or group of pesticides versus the pesticide screening?
The determination of an individual pesticide or group of pesticides tends to be associated with a shorter processing time and lower costs than pesticide screening. In addition, lower detection limits can usually be achieved than in a screening. This option is therefore particularly recommended if the used pesticides are known (spraying protocols).
Which particularities have to be considered for the microbiological examination of hemp products?
Hemp is a natural product with a very high background flora, which can suppress salmonella growth. This does not mean that salmonella is not present but rather that it cannot be detected. For this reason, a product-specific method verification is generally recommended for the detection of Salmonella in hemp.
How can I set appropriate microbiological limits for my product?
The following pharmacopoeia chapters are recommended as guidance for establishing the microbiological specifications for phytopharmaceuticals:
- Ph.Eur. 5.1.8: Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation
- 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use
How long does an antimicrobial effectiveness (AET) test take? It takes 5-6 weeks from the receiving of samples to the sending of the analysis results. During the test procedure, the product is first sampled with different microorganisms. Subsequently, any germ growth is observed over a period of 28 days. For this purpose, samples of the germinated product are taken at regular intervals and microbiological tests are carried out. The evaluation of the last sample can be performed at the earliest 5 weeks after the test has been started.
How can I set appropriate microbiological limit values for my product?
The manufacturer has to evaluate on a risk-based basis, for example with the help of the ISO standard 2962, which microorganisms could be introduced into his product in a harmful mass. This risk analysis is mainly based on the scope of the product and the consumer group. In general, infections via the mucous membranes of the mouth, nose or eyes are more likely than via the skin. With regard to the target group of the product, infants and persons with weakened immune systems tend to have a higher risk of infection than healthy adults. ISO 17516 is recommended as a basis for guidance in determining the microbiological specifications of a product.
What are the advantages of performing a product-specific validity check or, when is it absolutely necessary, for microbiological analyses?
INTERLABOR has extensive basic verifications of the various ISO methods for cosmetics. The ISO methods including preservative exposure test for cosmetic products with different matrices applied. This enables the corresponding tests to be carried out in the Framework of the ISO 17025 accreditation. If the performance of the analytics within the framework of GMP is desired, product-specific validity check of the methods are required. Besides GMP analyses, a product-specific validity check is generally recommended for the following cases:
- Matrices with germ growth inhibiting properties (e.g. certain essential oils)
- Non-standard matrices (e.g. body butter with very high fat content)
- Matrices with naturally high background flora (e.g. hemp)
Does INTERLABOR offer the creation of a product information file (PID)?
The current EDI (Eidgenössische Department des Innern) regulation on cosmetic products (VKos) stipulates that a product information file (PID) must be created by the manufacturer in self-regulation for each cosmetic product. An important part of the product information file is the safety report, which must contain the microbiological specifications of the product and the results of the preservative exposure test. INTERLABOR itself cannot create a PID, but can only assist in ensuring microbiological quality. Be it by carrying out preservative load tests or advice on the choice of specifications.
For which products is testing of Furocoumarins recommended?
The phototoxic, secondary plant substances are particularly common in citrus and food and spice plants of the umbelliferous plants. These also include lemons, oranges, bergamots and thyme, whose essential oils are a component for many perfumes and natural cosmetics. In addition to the ingredients, another important aspect of risk assessment is the application of the product. Under the influence of long-wave UV radiation, furocoumarins act as photosensitizers. Phototoxic effects with symptoms similar to sunburn can therefore occur directly after contact with sunlight. In addition, some furanocoumarins form adducts with cellular components such as DNA bases. Their potential photomutagenicity and carcinogenicity is based on these interactions. There is therefore a particularly high risk of harmful effects on health from furocoumarins in products such as sunscreen sprays or face and hand creams, as they are applied directly to areas of skin that are exposed to sunlight.
Dr. Simone Szymanski
Which parameters do I have to test for my products?
Since the revision of the food law, producers and importers of food are required by law to carry out self-controls. What parameters are controlled depends on the HACCP concept, which must be drawn up for each process and must also be submitted to the law enforcing body.
What are the requirements regarding multiple pesticide residues?
The legislator has not defined special requirements for multiple residues in the regulation of the EDI concerning maximum content for pesticide residues in products of plant or animal origin (VPRH). Organisations such as SwissGap have established rules for dealing with multiple pesticide residues, some of which have been adopted by retailers.
Is there a warning system for food recalls?
The Federal Office for Food Safety and Veterinary Affairs publishes recalls and public warnings of foods that pose a health risks.
The European Rapid Alert System for Food and Feed (RASFF) shows on its portal the hazards of non-compliant food and feed
Which carriers are used for indoor air analyses (aldehydes/ketones)?
The analysis is based on Dinitrophenylhydrazin tubes (DNPH; for example Supelco LpDNPH S10). However, other types or manufacturers can be considered after consultation of the feasibility. Please store the tubes in a cool place and observe the expiration date.
Does INTERLABOR take room air samples for the analysis of volatile organic compounds (VOC) or aldehydes/ketones?
No INTERLABOR only carries out the analyses. The sampling must be done externally. We will be happy to provide you with the corresponding references if required.
Do you send petri dishes for imitation examinations?
In individual cases we are happy to send plates, but in general it is easier if you order them directly from the manufacturers. We will be happy to provide you with the relevant reference data if necessary. Please store the plates according to the manufacturer's instructions and observe the expiration date.
Do you rent air samplers?
INTERLABOR does not offer air samplers for rent. However, we can provide you with external partners who specialise in this.
Dr. Olivier Aebischer
Head of Customer Service
How must the sample be sent?
There are special guidelines for this type of sampling, the requirements for the sample container and the sample transport. Microbiological samples must arrive at INTERLABOR refrigerated and within 24 hours. The sample container for microbiological tests should be sterile to exclude foreign contamination. We will be pleased to advise you on the choice of sample containers and give you tips on the sampling.
What are the maximum values?
The maximum values in drinking water, shower water and bathing water can be found in the ordinance "817.022.11 Ordinance of the FDHA on drinking water and water in publicly accessible baths and shower facilities".
Why can my boiler water not be assessed for legionella?
The EDI regulation on drinking water and water in publicly accessible baths and shower facilities does not set maximum values for hot water from a boiler, but only for shower facilities and whirlpools. The reason for this is that exposure is only present in these areas.
What is a sample?
At INTERLABOR, a sample is the total amount of material to be tested. The division of sample material into several sample containers is advantageous if, for example, both chemical and microbiological analyses are ordered.
How do pharmaceutical analyses differ from other analyses?
For the analysis of pharmaceutical raw materials, public analytical methods from monographs or general chapters from pharmacopoeias are available. The quality standard for pharmaceutical analysis is usually good manufacturing practice (GMP). This requires product-specific validated or verified analytical methods. In addition, the high standard with regard to documentation, control (4-eye principle) and Q processes (OOS investigations; deviation reports, CAPAs, etc.) is associated with a corresponding expenditure of time and money.
What does GMP mean for pharmaceuticals?
GMP (Good Manufacturing Practice) for medicinal products means a quality management system that enables the following aspects of pharmaceutical quality to be guaranteed:
- Consistent manufacture and testing of medicinal products in accordance with the quality standards of the respective competent drug authorities, EudraLex Volume 4 and the PIC/S GMP guidelines
- The medicinal products comply with the intended use and the specifications in the registration dossier
As a neutral and independent service laboratory, we see ourselves as an external part of the customer's quality control and naturally offer the performance of analyses within the framework of GMP.
What are the requirements for a GMP analysis?
For analysis under GMP, product-specific validated or verified methods are required. Furthermore, the conclusion of a quality agreement (QA) is necessary. The respective responsibilities and duties of the service laboratory and the customer are described in the corresponding agreement.
How do I set specifications and what are they needed for?
Specifications describe the range of tolerance, e.g. of an active ingredient, to which a pharmaceutical company commits itself vis-à-vis the authorities in the approval procedure. The specifications are planned, sounded out and defined during development and then guaranteed during production. The ICH Recommendation "ICH Q6A Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances" provides the general framework for the definition of specifications of active substances and finished products.
What is the difference between a proficiency test (verification) and a method validation? Basically, monographed, public methods (DIN/ISO) are verified and own or customer methods are validated. The basis of verification is a validated method. Verification of a compendial test procedure is a test whether the method can be used for the intended purpose with the equipment and conditions available in the test laboratory for the specified matrix. Validation of an own or customer method is the proof that the analytical procedure works for the intended purpose (proof of precision, accuracy, specificity, detection limit, linearity, working range and robustness).
Are OOS clarifications included in the costs of GMP analyses?
INTERLABOR distinguishes two phases of OOS clarification. In the first phase, an internal, intensive troubleshooting is carried out in the laboratory using a checklist. This is the proof that there is no obvious laboratory error. This clarification is included in the routine price under GMP. In a second phase, an extended, intensive examination can be carried out. As an example, a multiple analysis of the material can be mentioned. If the extended inspection substantiates the non-conformity of the material, the additional work performed will be charged to the customer. However, should a laboratory error become apparent against expectation, the costs will be covered by INTERLABOR.
Does INTERLABOR offer advice in the context of a cleaning validation?
INTERLABOR offers a detailed consultation in the field of analytical detection of possible detergent or product residues. We would be happy to guide you through the validation process. Furthermore, the corresponding methods for selected cleaning agents have already been validated internally and can therefore be carried out quickly.
Why are pharmaceutical analyses under „GMP“ more expensive than tests according to „state of the art“ or „ISO 17025“?
Work carried out in the GMP area is subject to additional processes that are not required under ISO 17025 and the state of the art. For example, all raw data is checked by a second person. Further work (Deviaton, Change Request, OOS-investigation) is carried out in case of deviations, planned changes or non-compliant results, which can be very time-consuming.
Decision support: Quality standards at INTERLABOR
|Supervised QM system||+||+||+|
|Standard operation procedure (SOP)||+||+||+|
|Verification and validation||optional||+||+|
|Archive duration raw data||10 years||10 years||20 years|
|Archive duration certificates||20 years||20 years||20 years|
|Quality agreement (QA)||-||-||+|
|Out of Specification (OOS)||optional||optional||+|
|Out of Trend (OOT)||optional||optional||+|
|Review raw data and CoA||optional||optional||+|
Can INTERLABOR also develop test methods and if so, what is the procedure?
INTERLABOR's extensive range of equipment and a broadly based research and development department enables us to develop tailor-made analytical methods for our customers. In a first step, the responsible client advisor will carry out a feasibility study in consultation with the departments involved. The next step is to prepare an indicative offer by outlining the development plan, the time schedule and the costs.
Does INTERLABOR also offer analyses within the framework of stability studies?
IA stability study should examine all the properties of the product that are susceptible to changes during storage and that have an influence on quality, safety and effectiveness. INTERLABOR offers a wide range of analyses for testing the consistent quality of a drug. Be it content tests of active ingredients, the detection of degradation products, the testing of microbiological quality or the determination of the disintegration time of tablets.
Which storage conditions does INTERLABOR offer for stability samples?
INTERLABOR has a large amount of space available for the storage of stability studies:
|-20 °C||Freezing room (10000 L)|
|20 °C (room temperature)||Sample storage room (35000 L)|
|5 °C||Cooling room (20000 L)|
|25 °C/60 % rH||Climate room (2 x 35000 L)|
|30 °C/65 % rH||Climate room (35000 L)|
|30 °C/75 % rH||Climate room (20000 L)|
|40 °C/75 % rH||Climate room (10000 L)|
|Variable (0 bis +60 °C)||Climate chambers (2 x 1000 L)|
|Variable (-20 bis +60 °C)||Programmable climate chamber (1000 L)|
|Relocation of stability samples to zones with -20, 5 or 20 °C|
Does INTERLABOR offer stress studies and if so, which ones?
Stress studies according to the ICH Q1B guideline as well as according to customer specifications can be conducted. For example, INTERLABOR has the necessary equipment to carry out photostability studies.
Do analyses have to be validated/verified according to pharmacopoeia?
The aim of validation is to show that an analytical method is suitable for the intended use. In general, methods from compendia such as Ph. Eur. or USP are considered validated. The primary aim of verification is to prove the suitability of an analytical method under the specific laboratory conditions. For example, to show that appropriately trained personnel and suitable equipment are available. Verification is therefore necessary for pharmacopoeia methods that are carried out in the laboratory for the first time. The chapter < 1226> of the USP can be interpreted as meaning primarily instrumental methods such as HPLC or GC methods for testing the content or purity as well as contaminants (pesticides, metals etc.) of raw materials and finished products. Whether a verification of a pharmacopoeia method is necessary is clarified at INTERLABOR during the order acceptance process. The customer is thus informed in advance about necessary verifications and any additional costs.
Dr. Olivier Aebischer
Head of Customer Service
Dr. Simone Szymanski