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Alhydrogel® Quality

Quality Basics:

Brenntag Biosector is GMP-certified by the Danish Medicines Agency as a producer of medicinal products. Consequently, it can follow all material flow from raw-material over final product to end-user. This further means that all critical production steps are subject to validation, that all suppliers are audited and that both raw material and final products are tested for compliance with the relevant monographs (USP, EP where applicable).

Incoming Control:

All the raw materials, including the water (Aqua pur.) are subject to a thorough incoming control to verify compliance with the relevant monographs and GMP.

Hygiene and storage:

The EP monograph 1664 recommends a storing temperature between 4 and 30 degr. Celcius. Securing a good hygienic standard during storage is essential for the products. Brenntag Biosector has carefully chosen transporters which can bring the products from its warehouse to a client's warehouse in a nice and clean condition. Measures must be taken to secure good hygiene during storage.

Under no circumstances should the products be stored outdoors, even for a limited period of time. Likewise, pallets cannot be placed on top of each other, as the weight of the upper pallet may damage the integrity of the lower pallet.

Quality-related statements:

Some customers request a certificate or statement that the products do not contain components of animal origin with reference to the concern about TSE/BSE, GMO’s or organic solvent residuals. As Alhydrogel is synthesized solely from inorganic salts, inorganic base and water, there is no problems issuing such a statement.

Sterilization of Alhydrogel®:

Alhydrogel® is sterilized by autoclavation and thereafter filled in the final container in a clean room environment.