OverviewRedditch Medical's InTact™ products are so named because TACT describes the key parameters involved in cleaning optimisation:
Description and Benefits
InTact™ Alkaline is a unique low foaming, low residue, Clean-in-Place (CIP) and Clean-out of-Place (COP) concentrated alkaline detergent formulation based on Potassium hydroxide, biodegradable surfactants and chelants. InTact™ Alkaline is designed exclusively for use in GMP Pharmaceutical and Medical Device Industries where rapid processing and rinsing is required. Validation is further supported with:
Use and Application
InTact™ Alkaline is suitable for use in all Clean-in-Place & Clean-out of-Place component washers and ultrasonic bath systems and Clean-in-Place systems. Monitoring systems can also make use of the data held on InTact™ Alkaline viscosity and conductivity at frequently used dilution rates.
If additional surfactancy is required InTact™ Acid is full compatible with InTact™ Neutral Booster – refer to Technical Datasheet/InTact Neutral Booster Rev 001.
InTact™ Alkaline is manufactured in an ISO 9001 and ISO 14001 registered facility with full batch traceability and complies with (EC) No. 648/2004 on detergent biodegradability.
InTact™ Alkaline is released with a certificate of analysis a two year expiration date for the date of manufacture. Safety data sheets (SDS) are available online or upon request.
Always wear gloves and goggles or face protection, protective clothing. Always read the label and MSDS before use.
Conditions for Storage
Store in the tightly-closed, original container in a dry, cool and well-ventilated place. Keep upright to prevent leaking. Keep only in the original container. Corrosive storage. Additional test work supports that InTact™ Alkaline is unaffected by low temperatures –see freeze/thaw study – ref Freeze/thaw Study Rev 001.
Additional Supporting Services - InTact Optimisation Studies
Redditch Medical offer a laboratory-based service in which stainless steel or glass coupons representing an end-users actual drug and excipient soiling are tested in our laboratory to determine which cleaning agent should be used and at what concentration, time & temperature whilst mimicking cleaning process conditions.
The results from these studies provide both the rationale behind product selection and an optimised starting point to move to a pilot or pre-qualification trial with high assurance of success.
The service can also assist in reducing current cleaning times and rinsing volumes.
Processed coupons are reviewed and examined via several criteria to rapid establish how effective the cleaning and rinsing process has been under each set of TACT conditions. Criteria are: