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We carry out microbiological and other testing on medicines manufactured at Royal Derby Hospital and from other NHS and commercial sources.
The unit is also involved in the viable and non-viable environmental monitoring of pharmacy manufacturing areas to ensure they comply with recommended standards for medicine manufacture.
The unit has been involved in the commissioning and recommissioning of clean room and theatre facilities for our own trust.
At Derby Teaching Hospitals Quality Control we provide a complete service for pharmaceutical clean room environmental monitoring requirements. From initial design and qualification to ongoing routine monitoring we can deliver a full and comprehensive service in full consultation with clients. We can also provide a routine monitoring and testing service.
Monitoring air quality in clean rooms and clean air devices is a critical parameter in the manufacture of pharmaceutical products, operating theatres, sterile services departments and other related pharmaceutical activities.
We can commission new clean rooms and clean room devices (isolators, LAFs, Biological safety cabinets etc.) as well as providing ongoing monitoring and testing so that the ISO 14644 and EU cGMP guidelines are met. The testing we can carry out includes:
The Derby team have a wealth of experience in pharmaceutical quality assurance that can be lent to for example quality research work, GMP and other forms of auditing, new facility commissioning and external inspection preparation.
The team have many years’ experience of GMP auditing which have been used for both internal and external customers. This includes pharmaceutical GMP auditing, supplier auditing and Wholesale Dealer’s License auditing with expertise used for example as preparation for MHRA, customer and Regional QC inspections. In depth reports are produced with recommendations for improvement and where required additional support to make suggested improvements can be provided.
Derby QC has carried out research projects for pharmaceutical industry including testing of the Tevadaptor® closed system transfer device. This was done in conjunction with BioPharma Stability Testing Laboratory Ltd (BSTL Ltd) based at BioCity Nottingham.
BSTL Ltd website: http://www.biopharmastabilitytestinglaboratory.co.uk/
We are keen to develop our research portfolio and work with pharmaceutical and pharmaceutical research companies.
If you require more information please contact:
Validation of temperature controlled storage and transportation is important because if healthcare products are not stored under specified conditions, stability may be compromised and shelf life reduced. Stability is compromised by temperature extremes or fluctuation. High temperatures increase the rate of degradation and decrease its shelf life. Inappropriately low temperatures may cause harm. For example, refrigeration may cause extreme viscosity in some liquid drugs and cause crystallization and precipitation in others. Freezing can denature proteins and can cause less soluble polymorphic states of some drugs to form.
The “cold chain” involves all of the storage and transport facilities necessary to ship a product requiring controlled low-temperature storage from the manufacturer to the end user. Thus the whole cold chain should be controlled and validated including transportation requirements.
Temperature control is also required for freezers, “cool” storage i.e. ‘between 8°C and 15°C’, ambient temperatures and for incubators e.g. ‘between 30°C and 35°C’.
There are several statutory and ethical requirements (listed below) which govern the storage of medicinal products, blood banks and departments responsible for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
The 'Orange Guide' indicates that:
"Internal air temperature distribution should be mapped on installation in the empty and full state and annually thereafter under conditions of normal use."
We currently carry out temperature control validation work for a number of customers including for pharmaceutical applications and blood banks. This includes the following types of work:
Incubation of media
The department has been providing an environmental media incubation and result reading service for internal customers for over 30 years and more recently external customers too. The department has 15 incubators for incubation of all commonly used environmental testing media. Media is routinely incubated at 20-25°C and 30-35°C with the incubation regime set up to meet the end users requirements. The incubators are monitored 24 hours a day by the calibrated Comark temperature monitoring system. Both liquid and solid media are routinely incubated including:
Plate reading can be performed between incubation change over (an interim read) and after completion of incubation dependant on the end users requirement. Plates are enumerated by trained staff with the level of organism identification agreed with the customer. Organisms can be read to genus level using common laboratory techniques or can be read to species level using our Gen III MicroStation micro-organism identification equipment.
Bespoke results data reporting systems can be set up using IT software suites with real time access to “live” data tables via a web interface. This includes direct data entry by RDH QA staff removing customer data input requirements and producing “live” update of graphical and data presentations to meet customer requirements. Systems are designed via direct consultation with customers. This also includes individual result exception reporting when out of specification levels are exceeded.
Liquid testing media is read dependent on the regime requested by the end user. Media can be read and rotated on a daily basis as required.
All sterility testing is carried out within our fully validated and assured dedicated clean rooms within an ‘A’ grade Laminar Flow cabinet. The clean rooms include a ‘B’ grade room where the LAF cabinet is housed and a dedicated and controlled support room facility. A sterility test may be defined as - 'a test that critically assesses whether a sterilised pharmaceutical product is free from contaminating microorganisms'.
The purpose of the test for sterility is to independently provide a means of verifying that any substance, preparation or article is sterile, in accordance with the requirements of the Pharmacopoeia.
There are two sterility methods employed at Derby Teaching Hospitals Laboratory:
Derby Teaching Hospitals laboratory provide Sterility Testing on a range of products, these include:
The QA Laboratory carries out routine water testing for internal and external clients. The department uses a manifold and sterile canister system that can be adapted for various testing regimes and micro-organisms using a variety of testing media.
All pharmaceutical water testing is carried out to ensure that British Pharmacopoeia (BP), European Pharmacopoeia (Ph.Eur.) and United States Pharmacopoeia (USP) requirements are met. Examples of testing carried out include:
Testing regimes can be set up to meet regulatory requirements dependent on customer request. As well as pharmaceutical water testing, testing can be carried out for potable water supplies, sterility services and the food industry. We can work with customers to provide testing to meet their demands.