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ALS has vast experience in supporting non-sterile, sterile and medical device manufacturers; truly understanding microbiology’s practical application and value within healthcare settings. We can help.
CONTACT USALS provide a range of microbiological testing and support services to ensure raw materials, finished products, medical devices and production environments are appropriately monitored for microbiological contamination.
With our dedicated GMP compliant laboratories, highly experienced staff, and extensive range of microbiological tests, ALS is able to provide cost-effective quality assurance. Many ALS laboratories offer both analytical and microbiological testing under one roof offering simplified Quality Control solutions.
ALS offers quality focused testing and proactively seeks to form long-term, mutually beneficial relationships. Our clients are accustomed to receiving high-quality data, technical support and open communication. The collaborative approach is underpinned by project and client managers, skilled and qualified client service teams, access to technical experts and a management team committed to service delivery. Performing efficiently & ethically, is ready to support the healthcare industries with trustworthy and reliable QC services.
ALS has vast experience in supporting non-sterile, sterile and medical device manufacturers; truly understanding microbiology’s practical application and value within healthcare settings. We can help.
CONTACT USTesting is supported in line with the harmonized compendial requirements for the Microbiological Examination Of Non-sterile Products and the Tests for Specified Microorganisms, typically by the Membrane Filtration or Plate-count methods. ALS performs method suitability assessments of the selected test methods, demonstrating recovery of micro-organisms in the presence of product, ahead of routine testing.
ALS routinely handles a broad range of sample matrices, including harsher antibiotics, API’s, disinfectants and preservative-laden aqueous formulations, which can necessitate neutralisation for the removal of antimicrobial activity paralleled to scientific demonstration of absent neutralizer toxicity. The suitability of the counting method must be demonstrated in the presence of product.
All ALS facilities strive to achieve industry best practice inclusive of recommendations set out in USP Chapter <1117> amongst others. While not exhaustive, Compendia acceptance criteria for the microbiological quality of non-sterile dosage forms is principally defined by the route of administration backed by risk-based impact assessments as referenced in USP <1111>. The need for additional controls of objectionable microorganisms should be determined for each product. Alternative criteria is applicable to drug substances, herbal medicines and dietary supplements although in any case, typical requirements include:
Whilst compendia are harmonized for most non-sterile dosage forms, testing is conducted in accordance with:
ALS can include further specified and objectionable microorganisms into testing regimes, such as isolates from environmental monitoring, where known risks persist.
Other test methods, including rapid microbiological methods, may be used for product testing, but will require validation to demonstrate their suitability and equivalence to the compendial methods. As Technical Projects, ALS can support the development and validation of alternative procedures.
Water Activity Determinations can be supported per USP <922> and Ph. Eur. 2.9.39 methods.
Antimicrobial Preservative Efficacy (AET), also known as Preservative Efficacy Testing (PET), challenges the effectiveness of the antimicrobial preservative system in nonsterile drugs in preventing the growth of microorganisms that may be introduced into the product during manufacturing or product use.
Preservative Efficacy Testing is required for all hydrous topical, and oral forms, which contain preservatives, and injections packaged for multiple doses, namely where the product environment (e.g. pH, Water Activity and preservation technique) can be conducive to microbial proliferation.
Suitability testing, as recommend by the compendia, demonstrates the validity of the selected procedure by experimentally demonstrating the recovery of target microorganisms in the presence of product. The preparation procedure should remove residual antimicrobial activity of the product by dilution, filtration or other appropriate inactivators.
ALS has extensive experience in verifying method suitability for a range of formulations and preservative systems and supports Preservative Efficacy Testing by various approaches, including:
Bacterial Endotoxin Testing and Sterility testing are routinely supported, the latter under strictly controlled aseptic environments, on sterile waters, drug products and medical devices.
Endotoxin testing is offered using a number of differing compendia methodologies, such as those prescribed by USP Chapter ⟨85⟩ and Ph. Eur. method 2.6.14, providing options for where one technique in isolation may not be suitable. The presence of endotoxins in a substance or product may be masked or enhanced by factors interfering with the reaction. An initial suitability test, a test for interfering factors, is routinely carried out on three product batches or preparations ahead of routine testing. ALS offers a position of:
Endotoxin testing can be performed in accordance with various compendial and standards:
Typically going hand in hand with Endotoxin, Sterility testing is supported by compendia methodologies Ph. Eur. method 2.6.1, USP Chapter ⟨71⟩ Sterility Tests as well as ISO requirements for medical devices. Membrane filtration is commonly employed where products are filterable with direct inoculation supporting unfilterable products. Method suitability tests are performed for all new products and whenever experimental conditions change or vary. In support of aseptic manufacturing, ALS also supports media fill simulations as well as Environmental Monitoring (see below).
Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganism, reactive gases, and other substances (USP <1207>). Container closure systems should maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life (Ewan, S. et al., 2015).
Based on the drug formulation (e.g. liquid or lyophilized) and the type of the container (e.g. bottle, vial, ampule and syringe etc.) various methods can be employed to perform the container closure.
Various CCIT techniques can be supported between ALS and our partners NUVISAN.
ALS can support particulate testing alongside microbiological testing of sterile drug products. Particulate contamination of injections and infusions consists of extraneous, mobile undissolved particles unintentionally present in the solutions. It is considered a critical risk with quality control testing commonplace throughout in-process controls and a mandatory testing requirement in release testing specifications. Particulate Contamination is predominately split into two forms: Visible and Sub-Visible. ALS commonly supports the following compendia in connection with the practical application of industry best practices:
Effective microbiological monitoring programmes support overall microbiological control within manufacturing facilities. In the case of aseptic processing, monitoring of cleanrooms RABS (Restricted Access Barrier Systems), and isolators typically includes compressed gases, surfaces, air, and any other materials and equipment that might produce a risk of contamination. Mandatory requirements are set for aseptic processing per USP ⟨1116⟩
Microbiological monitoring and control programs for non-sterile manufacturing are not yet as well defined by compendia or regulatory guidelines. In a similar vein to aseptic, the extent of monitoring depends upon the manufacturing activity although tends be driven by circumstance-specific risk assessments with sampling and testing proportional to supply chain risk. Sound scientific rationale is naturally expected and trend analysis of the generated data helps underpin understanding and effectiveness.
ALS offers a complete range of supportive testing for both Sterile and non-Sterile environmental monitoring programmes, including:
Incubation, enumeration and reporting of:
Inoculation of blank control plates for Growth Promotion / Fertility testing.
Water Testing (Performance qualification and routine monitoring)
Surface Monitoring
In addition to testing, ALS’ offers consultancy services and are proactive in supporting:
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