Wrt a raw materials warehouse, the critical parameters would be temperature and Humidity control and fresh air supply must overcome the CO2build up from people/equipment. What would the specification for DP (to atmosphere) and A/C rate be? I have not found any reference to the above specs that are required for a warehouse. Please help.
[quote=waynem]Wrt a raw materials warehouse, the critical parameters would be temperature and Humidity control and fresh air supply must overcome the CO2build up from people/equipment. What would the specification for DP (to atmosphere) and A/C rate be? I have not found any reference to the above specs that are required for a warehouse. Please help.[/quote],
raw material store storage condition is depend what raw materil put inside.normally not fresh air supply.
If the storage conditions of the raw material stored are for example 18 - 22 degrees celcius and max %RH 50, then that is the critical parameter for the product.I am trying to determine the air change rate and and if there is any differential pressure requirements that need to be attained aswell. As far as I am concerned, there is no GMP requirement for DP as the storage area is not of the particle generating sort. So cross contamination etc is not an issue. But what about the amount of fresh air that is required to be added to the re-circulated air to allow for employee comfort/safety?
Thanks for the help.
please study the every raw material storage condition base on MSDS, Martindale, USP and BP may be GSP
normaly the raw material in the storage is not directly expose to the enviroment( on the container), so u not need concern aboout the pressure differential.
Thanks for the help.
on the first, see MSDS list for all row materials you want to store in the warehouse. The same parameters will be your target. If you find only temperature request, than you will project only temperature controling into warehouse. Also, have in mind (technically said)…The temperature parametar is easy to keep under controling, but humidity is not. Especially, higher values (more than 70% Rh, for example) in that case you will need additional equipment into your HVAC system to decrease the humidity.
So, be careffully in setting.
The warehouse do not need to be ISO classified, you can call it ‘‘controlled-unclassified’’!!! It means…you set and control temperature and have an record in real time. Also, you need to make an temperature mapping the first time you start and after that time to time (based on RA calculation, Q plans etc…)
Regarding AC/Hr, 2-5 AC will be good, it is just about people inside to be comfortable. Fresh air at least 20% recirculated 80%.
Example from warehouse in my factory… temperauture range 20+/-5 C, humidity no requested, 2-5 AC/Hr 20% fresh air, not exposed to directly sunlight.
Hope it help you, rgds,
4.1 Precautions must be taken to prevent unauthorized persons from entering storage areas.
4.2 Storage areas should be of sufficient capacity to allow the orderly storage of the various categories of materials and products, namely starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.
4.3 Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required on the label (e.g. temperature, relative humidity), these should be provided, checked, monitored and recorded. Materials and pharmaceutical products should be stored off the floor and suitably spaced to permit cleaning and inspection. Pallets should be kept in a good state of cleanliness and repair.
4.4 Storage areas should be clean, and free from accumulated waste and vermin. A written sanitation programme should be available indicating the frequency of cleaning and the methods to be used to clean the premises and storage areas. There should also be a written programme for pest control. The pest-control agents used should be safe, and there should be no risk of contamination of the materials and pharmaceutical products. There should be appropriate procedures for the clean up of any spillage to ensure complete removal of any risk of contamination.
4.5 Receiving and dispatch bays should protect materials and products from the weather. Reception areas should be designed and equipped to allow containers of incoming materials and pharmaceutical products to be cleaned, if necessary, before storage.
4.6 Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel. Any system replacing physical quarantine should provide equivalent security. For example, computerized systems can be used, provided that they are validated to demonstrate security of access.
4.7 There should normally be a separate sampling area for starting materials in a controlled environment. If sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination. Adequate cleaning procedures should be in place for the sampling areas.
4.8 Physical or other equivalent validated (e.g. electronic) segregation should be provided for the storage of rejected, expired, recalled or returned materials or products. The materials or products, and areas concerned should be appropriately identified.
4.9 Highly active and radioactive materials, narcotics and other hazardous, sensitive and/or dangerous materials and pharmaceutical products, as well as substances presenting special risks of abuse, fire or explosion, (e.g. combustible liquids and solids and pressurized gases) should be stored in a dedicated area that is subject to appropriate additional safety and security measures.
4.10 Materials and pharmaceutical products should be handled and distributed according to GMP as defined in this document.
4.11 Materials and pharmaceutical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination.
4.12 Materials and pharmaceutical products should be stored in conditions which assure that their quality is maintained, and stock should be appropriately rotated. The “first expired/first out” (FEFO) principle should be followed.
4.13 Rejected materials and pharmaceutical products should be identified and controlled under a quarantine system designed to prevent their use until a final decision is taken on their fate.
4.14 Narcotic drugs should be stored in compliance with international conventions, and national laws and regulations on narcotics.
4.15 Broken or damaged items should be withdrawn from usable stock and separated.
4.16 Storage areas should provide adequate lighting to enable all operations to be carried out accurately and safely.
4.17 Storage conditions for pharmaceutical products and materials should be in compliance with the labelling, which is based on the results of stability testing (see Appendix).
Monitoring of storage conditions
4.18 Recorded temperature monitoring data should be available for review. The equipment used for monitoring should be checked at suitable predetermined intervals and the results of such checks should be recorded and retained. All monitoring records should be kept for at least the shelf-life of the stored material or product plus 1 year, or as required by national legislation. Temperature mapping should show uniformity of the temperature across the storage facility. It is recommended that temperature monitors be located in areas that are most likely to show fluctuations.
4.19 Equipment used for monitoring should also be calibrated at defined intervals.
See this, also…WHO 2003, G.1 Guide to good storage practices for pharmaceuticals, Annex 9 of the WHO Expert Committee on Specifications for Pharmaceuticals Preperations: thirty-seventh report, Technical Report Series 908
aarghh…sorry, I forgot this…
11 Appendix - Storage and labelling conditions2
Normal storage conditions
Storage in dry, well-ventilated premises at temperatures of 15-25 °C or, depending on climatic conditions, up to 30 °C. Extraneous odours, other indications of contamination, and intense light must be excluded.
Defined storage instructions
Drug products that must be stored under defined conditions require appropriate storage instructions. Unless otherwise specifically stated (e.g. continuous maintenance of cold storage) deviation may be tolerated only during short-term interruptions, for example, during local transportation.
The use of the following labelling instructions are recommended:
On the label Means
„Do not store over 30 °C" from +2 °C to + 30 °C
„Do not store over 25 °C" from +2 °C to + 25 °C
„Do not store over 15 °C" from +2 °C to + 15 °C
„Do not store over 8 °C" from +2 °C to + 8 °C
„Do not store below 8 °C" from +8 °C to + 25 °C
„Protect from moisture" no more than 60% relative humidity in normal storage conditions; to be provided to the patient in a moisture-resistant container.
„Protect from light" to be provided to the patient in a light-resistant container.
1This guidance has been prepared in close collaboration with the International Pharmaceutical Federation (FIP).
2The text was adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its 34th meeting (WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-Fourth report. Geneva, World Health Organization, 1996, Annex 5 (WHO Technical Report Series No. 863).
Thanks a million cubica! It is really appreciated that you took the effort to part with soo much information.