FAQs Archiv - Page 4 of 4 - QP-Engineering

Q: How important is GMP-compliant measurement technology for audits?

GMP-compliant measurement technology is an essential component of quality control processes in regulated industries and therefore plays a decisive role in audits. Companies that do not follow GMP guidelines or cannot prove during audits that they use GMP-compliant measurement technology run the risk of experiencing regulatory and quality problems. This can have serious consequences for business operations and lead to financial penalties.

Q: What does cleanroom class 1000 mean?

Cleanroom class 1000 refers to the US standard FED-STD-209E and allows a maximum of 1,000 particles (≥0.5 µm) per cubic foot of air. An ISO 6 cleanroom matches this level. This cleanroom class is suitable for many industrial and scientific applications, as well as some pharmaceutical manufacturing processes.

Q: Which cleanroom class is needed when?

The EU GMP Guide specifies which requirements a cleanroom must meet and which cleanroom is necessary for the manufacturing process. Every production step requires a different cleanroom class. Particularly sensitive processes, such as in medical production, require higher-class cleanrooms. The selection of a specific cleanroom class depends primarily on the maximum permissible particle concentration and the recommended limit values for microbiological contamination in the form of colony-forming units (CFU).

Q: How many cleanroom classes are defined by ISO?

ISO 14644 is a series of standards covering different aspects of cleanrooms and controlled environments. The included ISO standard 14644-1 is titled "Classification of air cleanliness" and defines the cleanroom classes. Cleanrooms are differentiated into nine cleanroom classes (ISO 1 to ISO 9), with Class ISO 1 cleanrooms meeting the highest requirements for air cleanliness.

Q: What is a GMP cleanroom?

GMP stands for "Good Manufacturing Practice" and applies to cleanroom operations as the standard for good manufacturing practice. A GMP cleanroom is a strictly controlled area where the concentration of airborne particles is minimized and monitored. This is done to maintain GMP quality standards. These standards are legally required and ensure that products are manufactured under hygienic, contamination-free conditions.

Q: What's the pH value of purified water?

Ultrapure water (Purified Water, PW) generally has a pH value that is nearly neutral, i.e., around 7.0 at 25°C. However, the pH value can vary slightly depending on various factors such as the environment and the temperature. If ultrapure water is exposed to the atmosphere, the actual value can be lower than the original pH value of 7.00. In this case, the pH value could drop towards 5.20 due to the formation of carbonic acid. This highlights the importance of strict control over water treatment processes and the quality of ultrapure water.

Q: How is pharmaceutical water produced?

Pharmaceutical water is produced using pre-treatment, reverse osmosis, ion exchange, ultrafiltration, and other procedures. The choice of individual treatment stages and methods depends on the requirements for the pharmaceutical water, whether it is for Water for Injection (WFI), Purified Water (PW), or other pharmaceutical qualities. The entire facility for the production of pharmaceutical water is qualified, validated, and monitored in accordance with applicable regulations and GMP standards to ensure the quality and purity of the water.

Q: What's the difference between purified water and distilled water?

Der Unterschied zwischen Reinstwasser und destilliertem Wasser liegt in der Herstellungsmethode, dem Reinheitsgrad und den Anwendungen. Reinstwasser wird speziell für sensible Anwendungen wie in der pharmazeutischen und biotechnologischen Industrie hergestellt und muss strenge Qualitätsstandards erfüllen. Die Qualität wird oft anhand des Widerstands des Wassers gemessen, der bei 25 °C einen rechnerischen Grenzwert von 0,055 µS/cm entspricht, was einem Widerstand von 18,2 MΩcm (Mega-Ohm mal Zentimeter) entspricht. Im Vergleich dazu liegt der Widerstand von destilliertem Wasser zwischen 0,5 und 5 µS/cm bei 25 °C. Destilliertes Wasser wird für weniger anspruchsvolle Anwendungen wie das Befüllen von Bügeleisen oder Batterien verwendet. Der Unterschied im Reinheitsgrad und in den Herstellungsmethoden macht Reinstwasser zur bevorzugten Wahl für hochwertige wissenschaftliche und pharmazeutische Zwecke, während destilliertes Wasser in weniger anspruchsvollen Situationen Verwendung findet.

Q: Which types of pharmaceutical water exist?

The requirements for pharmaceutical water vary depending on the intended use. In general, it is classified into different quality grades, including: Water for Injection (WFI) : This is the highest quality grade and is used for the production of injectables and parenteral medicines (administered by injection). WFI must be virtually free of any contaminants and microorganisms. Purified Water (PW) : This is highly purified water used in many pharmaceutical processes, such as the production of medicines, ointments, and creams. It must meet specific purity requirements to ensure that it is suitable for these applications. Water for Manufacturing (HPW) : Often used for the production of non-injectable medicines, where the purity requirements are less strict than for WFI or PW. Water for Dialysis (WFD) : Used for hemodialysis, a procedure for cleaning the blood in patients with kidney failure. It must be free of contaminants such as bacteria, endotoxins, and heavy metals to protect patient health.

Q: What is pharmaceutical water?

Pharmaceutical water is water that has been specifically prepared and purified for pharmaceutical and medical applications. This water must meet strict quality standards to ensure that it is free of contaminants and microorganisms. The production of pharmaceutical water requires dedicated water treatment systems and rigorous controls to ensure that the required quality standards are met.