Water for Pharmaceutical Industry

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The water used in the pharmaceutical industry, used both in drug synthesis, cleaning, as well as Water for Injection needs to meet strict quality requirements. Water Treatment Systems and process equipment for the pharmaceutical industry need to be sanitizeable by steam and for this reason materials are used that can withstand high temperatures.

The eight types of water used in the pharmaceutical industry are:

1. Non-potable

2. Potable (drinkable) water

3. USP purified water

4. USP water for injection (WFI)

5. USP sterile water for injection

6. USP sterile water for inhalation

7. USP bacteriostatic water for injection

8. USP sterile water for irrigation

 

Waste water generated by the pharmaceutical industry also needs to be treated to meet strict discharge limits. High COD waters and active pharmaceutical ingredients need to me removed. In fact there is published data and investigations that assert that pharmaceuticals are making it into the environment either through waste water discharge from pharmaceutical plants, through human sanitary waste and through lanfill waste leachate. Read this article for more info. Biological treatment is one method that is used, but if the COD is very high, incineration or Wet Air Oxidation might be needed.

Another important concept in the pharmaceutical industry is GMP and Validation.

Validation can be defined as process of establishing through documented evidence a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality attributes. A validated manufacturing process is one that has been proven to do what it purports or is represented to do. The proof of validation is obtained through collection and evaluation of data, preferably beginning from the process development phase and continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, systems, buildings, and personnel), but it also includes th

1.Cleaning Validation
Cleaning validation is carried out to ascertain the procedure and method adapted for cleaning of equipments , and aria , is capable of giving desired cleanness , cleanliness of equipment can be ascertained by caring out trace analysis of active ingredient of previous products active ingredient trace analysis . by doing rinse water analysis or swab test, this is quite good method to ascertain the complete removal of earlier products residue so as to avoid cross contamination we have provided a complete example document for cleaning validation here.

2.Process Validation
Process validation is carried out on the manufacturing process or steps , which are adapted for during pharmaceutical manufacturing . The process adapted in pharma manufacturing should yield a consistent results with respect to quality of product. The laid down process is crosschecked for evidence for efficacy , and the results are documented for each step.

FDA guidelines define process validation as follows

Process validation: The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

For example in manufacturing of tablets a final mixing step is validated by withdrawing samples from all points in mixer at intermittent intervals , and assay of active ingredients is done, results are plotted against respective sample points and time intervals , the ,most efficient time interval at which there are consistent and satisfactory result for desired content at all sampling point is considered to be the best for the process of final mixing step, and this best time interval point is again validated by crosschecking ,and documenting on further three batches. It is one of example of process validation , it can extend to other processes adapted in pharma manufacturing. e control of the entire processes for repeated batches or runs.

 

Key players in the pharmaceutical water treatment industry are:

Siemens Water

 

Compiled by Rami E. Kremesti