The Use of Hoses in Pharmaceutical Production

Hoses are indispensable in pharmaceutical production. For constructors and planning engineers, hoses are a quick solution—whether due to time pressure or a lack of alternatives. Merchants and pharmacists are often surprised: hoses that cost more per meter than highly polished stainless steel pipes? With delivery times of over 12 weeks? How do you handle hoses professionally? What should you look for when selecting, qualifying, and using them? 

Basic requirements - similar to those for pipelines

GMP also applies to hoses: they must be suitable for their intended use and easy to clean. The used materials must not negatively affect the quality of the product.

Material verification and certificates

While the gold standard for material certification is clearly regulated for stainless steel pipes in Europe (e.g., via DIN EN 10204 Types of test certificates for metallic products), the spectrum for hoses is significantly broader—and less clear. Common certificates and approvals for hoses that come into contact with products and pure media include:

• Listing of the material in the 21 CFR 177.2600
• EC 1935/2004 and EC 2023/2006 (food contact / GMP)
• BfR-positive list
• DVGW W270 (often sufficient, e.g. for purified water)
• USP Class VI (for components in equipment for injectable products)
• ADI-free (common in the biotech sector)
• Pressure Equipment Directive 2014/68/EU (for critical pressures and media)

The choice of certificates can be made on the basis of a risk analysis according to the intended use. Alternatively, there are also companies that, in order to avoid confusion and simplify materials management, only purchase and use hoses with “universal approval.”

Maintenance, pressure testing, and qualification

Depending on the area of application, recurring pressure testing may be necessary. Depending on the medium, pressure level, type of connections, and number of hoses used, it may be advisable to operate your own in-house manufacturing, testing, and maintenance facility, including trained personnel.
Note: In many cases, CE marking is not applicable because hoses are only placed on the market as a complete system (with connections).

The qualification should include the following specifications or examinations, among others:

• Cleaning, disinfection, and sterilization procedures
• Type of use (single-use/multi-use)
• Leach-out and swelling behavior (in direct contact with the product)
• Internal surface quality/particle release
• Proof of durability and testing procedures

The service life must also be specified:

• Maximum time after use before cleaning/sterilization is required
• Maximum operating time before cleaning/sterilization
• Maximum storage period before cleaning/sterilization or disposal

Cleanroom suitability—just as important on the outside as on the inside

Hoses used in clean rooms from class C upwards must be smooth inside and out. Hoses with an external fabric layer are therefore not permitted. Caution is also advised with ultra-pure steam hoses with steel outer braiding, the cleaning is also problematic.

Labeling and storage—clear and traceable

Each hose must be clearly identifiable. In addition to the medium, information on status, age, service life, intended use, etc. must be clearly visible—ideally directly on the hose. In practice, there is a wide variety of labeling solutions, some of which can be very complex.

The following also applies:

• Hoses should be stored dry
• Documentation of storage conditions (e.g., temperature, light protection).

Standards: State of the art

For further specific assistance with the selection, qualification, documentation, and use of hose lines in a GMP environment, reference can be made to the two standards DIN EN 16820:2017-10 and DIN EN 16821:2017-10.