Millipore Technical Publications |
 | Brochure - PB1150EN00 | |
Pure Assurance - Access QA/QC Services | ||
| Lit No: | PB1150EN00 | |
| Year: | 2002 | |
Quality services complement our quality products
A complete quality assurance solution means more than just reliable products. It means getting your testing methods and equipment validated, and producing results as quickly and accurately as possible.Millipore’s Access Services was established in 1987 to give resource-constrained QA/QC groups a welcome alternative to in-house methods development and validation. Whether you need a new method or protocol, on-site IQ, OQ or PQ, or a complete, company-customized validation package, we’re ready to lend a hand.
Save time and money
We can help develop streamlined methods that save you steps, time and money. And we’ll significantly shorten your time to validation with professional, pre-packaged validation protocols that include everything you need to achieve full compliance.
One less item for your to-do list
By taking care of the details needed to get your methods and equipment validated and fully operational, we can free up your staff for other important projects.
Compliance – and confidence
Millipore Validation Packages and expertise can reduce your risk, and make the job much faster and easier. With years of experience helping pharmaceutical and biotech companies successfully meet regulatory requirements, we’re familiar with current guidelines from the FDA, EMEA, and other regulatory authorities.
We not only share your sense of urgency, we share your insistence on getting the job done right. With Millipore, you’ll know – for sure – that you’re getting top performance from your equipment, in full regulatory compliance.
Laboratory Services and Methods Development
Millipore test methods are used in QA/QC labs of many leading pharmaceutical and biotech manufacturers around the globe. If you need to develop a new method or optimize an existing protocol, we can help you do it quickly and easily – in strictest confidence, of course.
Our scientists are available for consultation and project-based laboratory work at our state-of-the-art facilities. Typical assignments include:
- Feasibility and optimization studies
- Development of microbiological test methods to assay a variety of biopharmaceuticals
- Neutralization of antimicrobial additives or procedures
- Product compatibility testing
Standard Validation Packages
Millipore’s standard Validation Packages are an economical way to meet the needs of most laboratories, and are ideal for busy QA/QC departments. They not only save you money; they can lighten your workload, reduce paperwork, and get you up and running faster.
For many of our QC testing solutions – such as Milliflex, Steritest, M Air T, Sterisure and MicroStar systems – we provide a complete, ready-to-run validation package that consists of:
- A validation master plan
- A detailed specification
- Standard IQ and OQ protocols
- PQ guidelines that can be easily customized for your specific application
- A Validation Final Report format, with all necessary worksheets
Customized Validation Packages
Our validation experts will work closely with your validation team to create customized validation packages to meet highly individual needs. These are based on our Standard Validation Package, reformatted to conform to your company’s specifications, or to incorporate required modifications to test methods.
On-Site Validation
To save time, and minimize disruption of your normal workflow, we can also help you execute your validation study. All work is performed at your location by an experienced Validation Specialist. With validation complete, your test equipment will be ready for use.
Get the Access Services Advantage
Our dedicated team has the indepth product knowledge and the application expertise to deliver quality results every time, right on schedule. With 15 years of experience and research to draw on, there aren’t many microbiological testing or validation challenges we haven’t seen – and solved. In addition to the time and cost savings, you’ll appreciate the convenience and confidence that come with Millipore’s Access Services. MicroStar System