for the highest standards
Sampling for monitoring and analysis plays a large and important role for quality assurance in modern production processes. Very precise material analyses can be carried out using technical methods. However samples must first be taken professionally as taking samples incorrectly leads to inaccurate and therefore worthless analysis results. The purity of the sampler and devices used is a significant factor here. This is because the sample taken must not be affected by external factors as even the smallest external contaminations can falsify the examination result.
Reusable samplers made of stainless steel, aluminium, PTFE or similar inert high-quality materials are usually used. These have a high-quality and precise design free of undercuts so that no contamination can collect and the necessary cleaning is as simple as possible after use.
Disposable samplers are an alternative. These individually packaged plastic samplers are manufactured under clean room conditions and are even available optionally as sterilised samplers. Disposable samplers do not have to be cleaned before or after sampling as they are disposed of after use.
Reasons to use disposable samplers
In many application areas such as in the pharmaceutical sector, food & beverage branch or cosmetics industry, there are high standards for the sampler used to be free of particles and sterile so that the samples are not contaminated. The higher these standards, the more likely that they can only be met by using disposable samplers.
The following points should be observed when deciding on using disposable samplers:
Cleaning reusable samplers
Cleaning reusable samplers is costly and often complicated. Cleaning may even be impossible for greasy, strongly adhesive or toxic substances. The cleaning process also brings about high personnel costs and can disrupt other work procedures and processes. The required working time and the cleaning materials used therefore lead to high costs. For frequent use together with a high cleaning expenditure, it is therefore often significantly cheaper to use a disposable sampler.
Time is money - Compare the costs
- Bring to cleaning area
- Remove sampler
- Cleaning agent
- Work time
- Autoclaving in some cases
- Mount sampler
- Packaging if required
- Transport and storage
Due to the effort involved in cleaning and the costs associated with it, it is often more economical to use a Bürkle disposable sampler.
Audit and validation of processes
In the application areas stated above, there are high audit requirements based on GMP guidelines. The process and method of cleaning must also be validated as part of audits that take place regularly. However a validation of the cleaning process and therefore the verification of the effectiveness and reproducibility of the cleaning procedure is difficult and costly. A validation may even be partially impossible. The validation of the cleaning method is dispensed with entirely when using disposable samplers.
Safety for toxic, hazardous and aggressive media
If toxic or hazardous media are sampled, residues of these substances also involve risks for the health of employees when cleaning. Work safety measures are therefore necessary to ensure the safety of employees. In contrast disposable samplers can be disposed of simply and safely.
With the aid of disposable samplers. high-purity and sterile sampling is possible. As cross-contamination with previous samples or cleaning agents is excluded, correct and perfect analyses follow sampling. Reliable statements about the quality, properties and composition of samples can only be made with these types of representative and authentic samples.
Production and sterilisation of disposable samplers
The high demands for the samplers to be free of particles and sterile are achieved as a result of production in a clean room and a subsequent sterilisation by means of gamma rays.
In so-called clean rooms, the concentration of particles that are contained in the air are kept as low as possible using appropriate work clothes, materials and techniques as well as a special ventilation system. The respective clean room class defines the maximum number of particles with a corresponding size that may be present. To comply with the specified clean room class, the actual number of particles must be controlled regularly. In this way, the number of particles on the surface of the sampler can be kept very low due to production in the clean room.
In addition the samplers are then sterilised by high energy, ionising gamma rays. As a result, all micro-organisms on the surface of the samplers are killed off. The irradiation takes place in the packaging so that the samplers cannot be re-contaminated by subsequent packaging work. The procedure is also very gentle on materials as it does without a temperature increase.
To maintain the highest standards with regard to purity and sterility, Bürkle has developed the DispoSampler product line. These disposable samplers from the LaboPlast® and SteriPlast® brands are produced, mounted and individually packed in a class 7 clean room (10,000). The SteriPlast® Disposamplers are then sterilised with gamma rays. All products comply with EU food requirements and FDA regulations.
There are samplers for fluids and viscous media as well as for powders and granulates available. With the aid of these, target-point samples, multiple layer samples and cross-sectional samples can be taken.
Disposable samplers can help to save time and costs and also ensure a correct analysis result in areas with high standards for sampling.
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