A Perfect Complement to Sartorius’ Offering

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Sartorius Acquires New Lab and Bioprocess Businesses

Sartorius successfully closed the acquisition of leading life science businesses from the Danaher Group. All portfolios represent an excellent fit, adding best-in-class technology for simplifying drug discovery and advancing bioprocessing to Sartorius’ already strong offering. The teams involved look forward to combining capabilities and serving their biopharma and life science customers together. 

Acquisition of Selected Assets of Danaher Life Sciences
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Explore the New Portfolio

Chromatography

Columns, systems, resins and membranes for chromatography in Single-use, Multi-Use and intensified bioprocessing, for all scales.

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tangential flow filtration

Tangential Flow Filtration

TFF solutions in various formats for all stages and scales of concentration/buffer exchange, from process development to cGMP production.

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Microcarriers

Our protein-coated & animal product free microcarriers promote excellent cell attachment and growth for a broad range of anchorage-dependent...

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ForteBio’s Bio-Layer Interferometry (BLI) Systems

BLI systems complement Sartorius’s overall offering to our customers engaged in drug discovery/development and biomanufacturing

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Services

Our Service Teams are on hand to provide technical guidance and support for our new Chromatography and TFF Customers. Please get in contact with...

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Particle Validation Standards

This line of custom-manufactured standards is designed to validate the visual inspection process used for Quality Assurance.

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Brands Now Part of the Sartorius Family

Allegro™ Single-Use Chromatography Systems and

Allegro™ Single-Use Tangential Flow Filtration Systems:

Allegro™ CM150 - For Small Scale SUTFF Processing

Allegro™ CS1000 - For Process Control and Ease of Use in Clinical and Production Scale

Allegro™ CS4500 - For Control, Flexibility and Ease of Use in Manufacturing

Allegro™ is a trademark of Pall Corporation used under non-exclusive and timely limited license.

Hillex® Microcarriers - Microcarriers with polystyrene core and cationic amine-modified microporous surface

IEX Resins:
HyperCel™ Star AX

Mixed-Mode Resins:
CMM HyperCel™ - Aminobenzoic Acid
MEP HyperCel™ - Mercaptoethylpyridine 
HEA HyperCel™ - Hexylamine
PPA HyperCel™ - Phenylpropylamine

FAQ | Frequently Asked Questions

Over Arching Questions

Q: What are the lead times? Who can confirm them for me? 

A: Your local Sartorius Customer Service is your single point of contact. Lead times (order to delivery) will vary with product and the current order and stock level situation. Order confirmations will contain expected delivery dates. For advance information, please discuss your needs with your account manager 

Q: Who do I order my consumables (single-use flow paths) from? 

A: Consumable can be ordered from the local Sartorius Sales Organization. Please follow the link to find your local Sartorius Sales Organization. https://www.sartorius.com/en/general-contact/local-contact  

Q: Will there be any change to my current supply chain/manufacturing site change/part number/ material changes/ packaging/certificate of quality, etc. to my SAP/enterprise system set-up?  

A: We will continue with the supply chain we inherit and review this over a period. If it currently works – it won’t be changed. The manufacturing site will remain the same initially. 80+% of part numbers will be transferred as they are - no change planned (GMP part no's need to change as there are too many digits for our SAP to handle). CLP (Classification, Labeling & Packaging) regulations will affect how quickly we can relabel Pall products to Sartorius. Our EH&S and Quality/Ops teams are reviewing this as a wider package of work. 

Q: I have a project in progress with Pall, who will be my new contact person (name)? 

A: There will be no change - you can continue with the same project contact. We will contact the customers with projects-in-play to provide banking details for transferring orders to new legal entities/payments due. 

Q: Who is my main contact for order-related questions? 

A: Your local Sartorius customer service representative will be your primary contact as for any other Sartorius product you are purchasing  

Q: What will happen with the existing open orders? 

A: Existing open orders will be migrated in the Sartorius ERP system  

Q: Do I need to place a new order replacing my existing order? 

A: No. Sartorius will, however, require approval to further process your order and deliver/invoice from Sartorius 

Q: Will Incoterms of an existing order remain valid? 

A: Yes 

Q: Who is my main contact for order-related questions? 

A: Your local Sartorius customer service representative 

Q: How to place my new orders? 

New orders can be sent either to your local Sartorius Customer Service representative or the generic e-mail address: DHR.BPS.TaskForce@sartorius.com   

Q: At which entity do I place my order? 

A: Orders are to be addressed to the entity mentioned on the Sartorius quote. If you order from an existing quote, please contact your local Sartorius contact who will advise on the right entity. 

Q: Do I need a new quote before placing an order? 

A: Existing quotes remain valid for the entire validity as mentioned in the quote. 

Q: Who do I go to with my inquiries? 

A: The assigned Sales Rep (Account Manager) is responsible to handle and qualify leads. Regarding technical qualifications, an application specialist can provide support if required.

Q: Who should I contact for support on an existing system, breakdown, periodic maintenance, online assistance, software bugs, training etc.? 

A: All customers will receive a letter which will include contact details for service requests. So please refer to the letter for contact details. 

Q: Are spare parts numbers changing? Can I use the same part numbers? 

A: Yes, please use the same part numbers as before. Our Sartorius service team will take care of your order afterward. 

Q: How fast is the quote process for standard spares, unusual spares, and equipment? 

A: Usually the quotes for spares will take between 1 to 3 days. Please consider some delay at the beginning as our administrative team members may have to review your configuration first to find the best solution for you. 

Q: Will you stock spares for me if I sign a service agreement for non-standard spares 1200mm through 2000mm? 

A: If you will sign a service contract with Sartorius, you are more than welcome to include a customer-specific spare part support into the agreement. This could include critical spares as well as non-standard spare parts. Please be aware that non-standard spare parts need to be stocked on the customer site. 

Q: Will you stock spares like Pall used to do in my region? 

A: Sartorius will continue to provide the same support for you as in the past. 

Q: Which customer service teams are responsible for product orders? 

A: Your local customer service will be your first point of contact. 

Q: In the case of any changes, what would be Sartorius’ plan in terms of customer notification and change control process? What would be the timeline for such an activity and the date for the last order for products manufactured by Pall? 

A: Local Customer Service representative will inform you about any order-related changes as soon as they appear. For other product-related changes, the standard Sartorius change control process will apply. 

Q: Where are the single-use flow paths (consumables) manufactured? 

A: Pall Portsmouth UK or Westborough MA. 

Q: Are the flow kits delivered with the Pall or Sartorius labels/ part numbers/ certificates of quality? Where can I find this information and sample pictures or documents? 

A: Changing labels to Sartorius branding will take some time. Approximately 80% of the product code numbers will remain unchanged. Quality Certificates ad Certificates of Analysis will be available from Sartorius for the products we sell. 

TFF (Tangential Flow Filtration)

Q: Do Sartorius cassettes fit the Allegro™ SU TFF systems?  

A: Yes, Using Sartorius adapter plates the Sartocon and Sartocube cassettes can be used in the Pall Filter holder.  For the PD unit, Slice 200 holder or Slice SC cassettes.  Some guidance is needed (e.g. installation parameters (torque).  

Q: What about the cassettes already used in these systems? 

A: If customers must use Pall filters, they must purchase them from Pall. ​ 

Q: What will be the date for the last order for products manufactured by Pall? 

A: Day 1. Due to CLP regulations, we will still be supplying equipment/consumables/spares with Pall logo until we have registered all sites as Sartorius and complied with local/EH&S regulations 

Q: We bought an Allegro System: Where do I buy required spare parts in future?  

A: Through the Sartorius BPS Service Team. 

Q: How long will Sartorius be able to sell the former Allegro Design? If it will change, how will Sartorius support me? 

A: Design changes for improved system operations are a normal procedure for manufacturers. If a new improved system arrives the required support will be covered by the Sartorius Technical Support Team. 

Q: What will happen to Pall brand names such as Allegro? 

A: Sartorius has acquired the right to use certain Pall brand names for a limited period. These include e.g. Allegro. We will also use the name BioSMB, but will not use Cadence. During the transition period, Sartorius will develop its future branding. 

Q: How can I order and install a new bag holder size? 

Different configurations are possible, and no service will be needed. The first system will come with 1 bag holder and customers can add another bag holder in the future as desired. For qualified systems, service might get involved to perform a customer SAT to qualify additional equipment and configurations. 

Q: Who do I get the Pall TFF cassettes from? 

A: These need to be ordered from Pall as usual. Sartorius is not acquiring any of the TFF cassettes from Pall. 

Q: We bought an Allegro System: Where do I buy required spare parts in the future?  

A: Through the Sartorius BPS Service Team. 

Q: Who do I order my consumables (single-use flow paths) from? ​ 

A: Consumables can be ordered from the local Sartorius Sales Organization or at DHR.BPS.TaskForce@Sartorius.com. Please follow the link to find your local Sartorius Sales Organization. https://www.sartorius.com/en/general-contact/local-contact 

Q: What about already used cassettes in these systems?  

A: Customers that want to continue to use Pall membranes and Cassettes will have to purchase those directly from Pall. 

Q: What about already used cassettes in these systems?  

A: Initially this information is expected to be provided by the respective site leads; as we learn more about the businesses per site we will have a better idea of the best person to contact/set up a mechanism that reports back specific Ops info per product family (like existing Ship card)

Chromatography

Q: Difference between Linear and Manual Columns? 

A: Both column types are based on high resolution, low-pressure drop design features - 3-position central nozzle valves, mobile phase flow path, and flow distribution cells design. Both allow column packing, unpacking, and CIP within a closed system. While even manual columns can optionally have remote control nozzle valves, automated liner columns allow fully automated unit operations. In addition, linear columns feature unique multi-axis piston control and precision linear actuation. For automated linear columns, no slurry packing station is required. 

Q: What are the benefits of auto columns? 

A: Automated column operations simplify and reduce risks at any scale but are particularly helpful for larger columns. Reliable, consistent packing, easier handling (less operator training), no additional packing stations needed, hoist free non-swing-out maintenance (last 2 both mean less cleanroom space), and complete use of resin slurry possible. 

Q: What is multi-column chromatography (MCC)? 

A: In biotherapeutic manufacturing, MCC has so far been used primarily for the pA capture step of Mab processing. Involving simultaneous use of multiple columns, continuous chromatography is more specifically known as multicolumn countercurrent (MCC) or simulated moving-bed (SMB) chromatography. Steps performed repeatedly during batch chromatography run simultaneously in different small columns (“zones”) during continuous chromatography. Product breakthrough is allowed in the load zone of the first column, with the second-pass column capturing that breakthrough. This approach greatly increases the first column’s binding capacity over what is observed in batch processes, reducing the quantities of resin required often by up to 80%. The use of a continuous loading zone improves processing efficiency so that column size can be smaller than that required for batch processes, in which loading pauses each time the column is cycled. Importantly, all batch process steps are maintained, and the same sorbent chemistries and buffer solutions can be used. 

Q: Does Multi-Column-Chromatography enable intensification? 

A: Yes, Multi-Column-Chromatography - also called multi-column capture (MCC) or continuous chromatography - has been widely used as the preferred technique for intensification of chromatography capture steps for modern processes. MCC permits extremely efficient use of resin capacity and 'continuous' use of the columns, as there is no waiting for non-loading steps to finish. Less resin is required, smaller pre-packed columns can be used, buffer consumption is optimized, and productivity is increased enormously. 

Q: What is the difference between intensified and continuous process? 

A: Process Intensification: Process intensification is the desire to maximize the overall productivity of the unit operation(s) or the process or the facility with a holistic bioprocessing perspective Continuous Process: Performing a process of interconnected continuous unit operations, without (large) intermediate holding tanks, through which the product travels in a (seemingly) constant flow to the final product. A continuous process represents the highest level of process intensification that a customer can achieve 

Q: What type of software is used in the auto columns? 

A: Resolute® Linear columns are controlled using a handheld touch screen remote control. The software is purpose-coded for the remote control and is designed to be intuitive. The fully automated system includes four main sequences as standard. Each sequence has configurable parameters so that it can be adapted to a variety of requirements. 

Q: In what sizes are both the column types available? 

A: Manual: 280 to 1200 mm (to 2000 custom), 100-400 mm stroke length is standard, an acrylic tube is standard. Linear: 350 to 2000 mm, 50 to550 mm packed bed capability, acrylic is standard, different grades of stainless steel available. 

Q: What are the materials of construction for both the columns? 

A: Resolute® columns are available with either acrylic or stainless-steel column tubes (no stainless steel for 280 mm). For more detailed information and other product contact materials used in our columns, please see the data sheets Resolute® Manual and Resolute® Linear. 

Q: Do you provide pre-packed columns? 

A: We have prepacked columns for resin screening and process development. We offer 1- and 5-mL columns and have 200 and 600 uL RoboColumns for HTPD. Larger pre-packed columns can be organized via recognized 3rd party providers. 

Q: Will I be allowed to do packing trials at your facility (In Americas/Europe) to qualify a new resin?  

A: Packing trials will be possible at our facilities with support from column packing experts. Not all columns in all sizes are available. Non-Sartorius resins and large volumes of unused resins need to be supplied by the client. The initial location for such services will likely be Portsmouth UK, with possible additional sites later. 

Q: Will you be able to pack competitor resins in the columns like Pall has done in the past (In Americas/Europe)?  

Yes, we will have experts on the team who know or can develop packing methods for any commercial resin in Resolute columns. The Sartorius locations for these services are not finally defined at this point, but likely there will be locations in EU, NA and Asia. Packing support will also be possible on-site at customer locations. 

Q: Can the PKP skids used for pilot scale manufacturing? 

A: These systems are suitable for small-scale production or process optimization, in addition to manufacturing biotherapeutic molecules according to GAMP guidelines and under cGMP. 

Q: How easy is to transfer process parameters/ method that have been developed from an Akta PD/ Pilot system? 

A:  In general transferring chromatography methods between different systems (assuming both are batch mode) is not a problem, although of course the software on ÄKTA systems and PKP/PK systems are different and allowance should be made for e.g. different system void volumes. 

Q: What is the exterior and interior surface finish? 

A: The pipework is 316 L stainless steel, interior Ra ≤ 0.8 μm, to 0.4 μm, electro polished. Exterior may vary depending on customer requirements. 

Q: What is the flow rate range for both the PK and PKP skids? 

A: PKP and PK skids come in several sizes each, covering flow rates ranges from 1-150 L/h and 10-4000 L/h, respectively. 

Q: What is the value that a customer will have from the Allegro™ Chrom skid? 

A: It is a versatile SU Chromatography Platform for all chromatography stages (flexibility and cost-effectivity). It offers reduced turn-around and changeover times between batches and campaigns and is usable with (pre-packed) columns or membrane adsorbers (stepwise intensification). 

Q: What type of automation is used? 

A: The Process Step Editor is PLC based automation and complies with CFR21 Part11 and cGMP guidelines.  

Q: What are the flow ranges? 

A: Flow rates between 10-500L/h (3/8“tubing) and 20-900L/h (1/2“tubing). 

Q: Can the skid be used for isocratic and gradient modes? 

A:  Yes, it is possible. Different flow paths are required. 

Q: Can the system be used for Pilot, clinical and commercial manufacturing? 

A:  Yes, the Allegro™ SU chromatography systems is designed to meet requirements of cGMP manufacturing and is documented accordingly. 

Q: Can one system be used for the entire mAb process covering bind/ elute and flow through steps? 

A: Yes, it is possible. Depending on your process requirements, different flow paths may be needed. The column operation range is 10 – 60 cm diameter pre-packed or conventional and membrane chromatography capsules. 

Q: Are the flow paths gamma-irradiated? 

A: The flow paths (manifolds) are provided in 4 sections, gamma-irradiated and double bagged 

Q: How can I integrate this system to a SCADA/ DCS network? 

A: The Process Step Editor is PLC based automation complies with CFR21 Part11 and cGMP guidelines. Supervisory control and acquisition of (SCADA, Siemens PLC WinCC) process data is captured using the integrated analytical tool software module via open platform communications (OPC) and saved to a discrete database. Ethernet network capability. 

Q: Can the system be equipped with Emerson/ Rockwell automation? 

A: Robust Step Editor common software platform used on Allegro™ SUTFF and chrom systems. Siemens PLC WinCC (SCADA) available now. Wonderware SCADA + Allen Bradley PLC for Americas. 

Q: Can the skid be used for a membrane adsorber based process? 

A: Yes. 

Q: What are the typical column volumes the system can handle? 

A: The system can fit up to 56.5L column volumes (up to 60cm in diameter with 20 cm bed height), running at 300 cm/h. 

Q: What is the typical membrane adsorber volumes the system can handle? 

A: This will depend on the operating flow rate (MV/min) you want to run the device at. With 1/2" tubing and flow rate up to 900 L/h, you can run 800 mL Sartobind devices at almost 20 MV/min and a 2.5L device at just over 5 MV/min. 

Q: What are the typical throughputs the system can handle for mAb processes? 

A: As a guideline, an Allegro™ system with 3/8" flow path is suitable for processing 1000L bioreactors, using a 40cm id, 20cm BH column and 3 cycles for pA, 1 for IEX. Similarly, Allegro™ with a 1/2" flow kit can handle output from a 2000L bioreactor with a 60 cm ID column with 20 cm BH column, same cycle numbers. Examples assume 300 cm/h flow rate. Of course, exact throughput calculations will depend on product titer and resin DBCs. 

Q: Can the BioSMB be connected to an acrylic column instead of pre-packed columns? 

A: Yes. 

Q: Does the entire operation need to be closed (flow-paths and columns)? 

A: In general, chromatography is not a sterile or a fully closed operation. That is no different for Multi Column Chromatography. But the use of pre-packed columns and gamma irradiated SU flow paths in a functionally closed system can greatly reduce bioburden and lower risk to product and operators. 

Q: Are the flow-paths gamma-irradiated? 

A: The manifolds are supplied individually, double bagged and gamma irradiated. For the SMB 80, the flow path is supplied in one piece. The SMB 350 comes in 4 parts. 

Q: Is it possible and necessary to gamma-irradiate a resin in a pre-packed column? 

A: Prepacked columns for production are normally packed in controlled classified clean rooms, using buffers prepared under similarly stringent conditions. Assuming compatibility with the resin, pre-packed columns can be cleaned and sanitized with NaOH. This is a recommended operation before use in a process. Several studies and patents have recently reported investigations of gamma-irradiation of pre-packed columns, notably also containing pA resins. No commercial products are currently available. 

See for example: https://www.genengnews.com/magazine/300/supplement-bioburden-control-in-continuous-capture-of-monoclonal-antibodies/ 

Q: What are the typical column volumes the system can handle? 

A: This will depend on which pump module is being used and the max. flow rate. The BioSMB 80 is designed for perfusion-based bioreactor processes that will run for longer periods of time. The BioSMB 350 is designed to manage batch process up to 2000L volume. This volume (3g/L) is to be processed in 6-8 hours with up to 8 columns. Typical examples found on-line use four to six columns with volumes less than 10L. 

Q: What type of automation is used? 

A: PLC - for systems in EU, Siemens is used. For US, Wonderware/Allen Bradley. Delta V appears possible in custom projects. 

Q: Can the system be used for cGMP manufacturing? 

A: The BioSMB 80 and 350 are designed for use in GMP manufacturing. 

Q: At what step in the process is BioSMB recommended for use? 

A: To fully obtain the productivity, footprint and cost related to resins, buffers and labor- it is recommended to use the BioSMB at the 1st chromatography step which is usually carried out in a capture/ affinity mode. 

Q: What value does the stainless-steel system bring to the customer? 

A: PKP and PK chromatography systems cover a full range of applications with the highest standard in design principles and operating protocols. We provide process solutions with both standardized and fully customized products and offer comprehensive support. Conformance with critical industry standards and full documentation packages. Flexible, proven, user-friendly. 

Q: What value do the columns bring to the customer? 

A: Replace manual to automated equipment to save labor needed during packing/un-packing activities, risks related to packing failures as well as process costs due to resin wastage and damage incurred from the column packing/unpacking process. 

Q: Will support be provided for IQ/OQ of the columns? 

A: In addition to the comprehensive documentation supplied with Resolute® columns, our Service team can provide IQ/OQ support for columns, documentation and execution, based on your requirements. Please discuss your needs with us. 

Q: Do you offer training and support on column packing with any resin? 

A: Yes, we have column packing experts who can offer training and support packing any resin in Sartorius columns, as well as Sartorius resins in any other marketed column. 

Q: Do you offer installation, qualification and training services for PK/PKP & Allegro systems? 

A: Yes

Solohill® Microcarriers

Q: What weight quantities do microcarriers come bottled? 

A: Depending on surface area bottled non-sterile microcarriers come with the following quantities: 10 g, 100 g, 500 g, and 1,000 g. 

Q: When would microcarriers be beneficial to introduce in the process? 

A: As early as possible as microcarriers offer a valuable alternative to roller bottles and fixed-bed bioreactors when working with adherent cells. 

Q: Are the microcarriers sterile? Do they require hydration? 

A: Microcarriers are non-sterile and do not require hydration or pre-swelling. Bioburden-reduced and gamma-irradiated microcarriers are available on a custom basis. 

Q: How does one sterilize microcarriers? 

A: Microcarriers can be sterilized by autoclaving with appropriate validation or by gamma irradiation 

Q: How do you know when it's time to harvest cells off of the microcarriers? 

A: Depends on the cell line and process setup. Refer to protocols on microcarrier handling, cells visualization on microcarriers, and quantitative measurements of cell attachment and growth.   

Q: How are cells harvested off of the microcarriers? 

A: Users can employ standard cell culture enzymatic harvest methods for detachment of cells from microcarriers. Usually steps using Ca/Mg-free DPBS, EDTA and Trypsin allow cell harvest from microcarriers (see protocol for further information). We recommend the trypsinization process to be optimized for each cell type. 

Q: What is the average cell growth rate for each of the microcarrier products? 

A: Cell growth rate is dependent on cell line and its environment (e.g. media, supplements, agitation/aeration, etc). We recommend checking the small-scale microcarrier screening protocol to help you understand how to obtain quantitative measures of cell attachment and growth. 

Q: What is the difference between Animal Protein coated and Animal Product Free microcarriers? 

A: Animal protein free (APF) microcarriers include APF verified raw materials and comes in 4 different types microcarriers (based on composition, surface chemistry, etc). The protein coated microcarriers are coated with porcine Type 1 collagen (gelatin) to improve cell attachment and growth. Fast Attachment Collagen Treated (FACT) microcarriers utilize a proprietary surface modification of the collagen layer to enhance performance. 

Q: What are the benefits of using protein coated VS animal product free microcarriers? 

A: Animal protein coated microcarriers provide flexibility with excellent attachment and growth across multiple cell lines. They are however incompatible with animal-free, serum-free processes. Animal protein-free microcarriers offer high performance options to limit or remove animal sources from their processes. 
 

Q: Is it possible to get a sample of just one of the microcarriers? 
A: We offer sample starter kits with 5g of each microcarrier type, not samples of a unique microcarrier.  

The standard starter kit contains 5g of each Hillex® II, Plastic, Plastic Plus, Star-Plus, Collagen Coated, and FACT III microcarriers. 

The Animal product free (APF) starter kit includes 5 grams each of: Hillex ® II, Plastic, Plastic Plus, and Star-Plus microcarriers. 

Q: Is a certificate of proof available proving that the raw materials used to create the Animal Product Free Microcarriers are animal free? Is this something Sartorius could provide? 

A: Yes, Quality Assurance at Sartorius can provide a certificate. 

Q: Will Sartorius provide in-lab training or support for microcarrier selection? 

A: Refer to the microcarrier protocols on usage best practices and small screen studies for the microcarriers starter kits. Additional application notes will also be available. Our technical sales experts and application specialists will support you in selecting proper microcarriers. 

Q: Will microcarriers still be delivered in the Allegro™ Microcarrier Delivery System? 

A: Yes. Allegro™ Microcarrier Delivery System kits for evaluation are delivered sterilized by gamma irradiation (< 25 kGy) and contain 100g of a specific microcarrier. Quantities of microcarrier can also be customized (30 grams to 8 kilograms per AMDS). 

Q: Are custom amounts of a specific microcarriers available? 

A: Yes, custom quantities of microcarrier can be delivered in Allegro™ Microcarrier Delivery Systems (30 grams to 8 kilograms per AMDS). They are delivered sterilized by gamma irradiation (< 25 kGy) 

Solohill® Particle Validation Standards

Q: What are Particle Validation Standards? 

A: Custom-manufactured standards to validate visual inspection for unintentional particulate contamination during the quality assurance check of pharmaceutical production. 

Q: What are the criteria for determining the material type for particle validation standards? 

A: After investigating potential sources of material contamination, Particle Validation Standards may be selected which fairly represent those possible contaminants. As an example, the following guidelines represent standard contaminants by container type: 

  • Ampoules – Glass & Fiber 

  • Vials - Glass, Fiber, Rubber Stopper & Aluminium 

  • Syringes – Glass, Fiber, Plunger Material & Stainless Steel 

Additionally, potential contaminants or conditions unique to each process may be included, such as overfilled and underfilled standards, plunger position standards, cosmetic defects and blanks. 

Due to material properties, Tyvek and cellulose fibers cannot be accurately characterized for inclusion in Particle Validation Standards. Tyvek and cellulose custom particles are not available currently. Nylon and polyester fibers are available as an alternative. 

Q: Can containers be supplied to create particle validation standards? 

A: Yes – customers are required to supply glassware. Containers must be provided in the same quality and cleanliness conditions as the containers used in your current manufacturing. To achieve this, containers should be collected after the washing procedure, but before filling. If that is not possible or practical, unopened containers from your glass supplier may be provided. 

Q: What stoppers can be used for particle standard closure? 

A: Rubber stoppers with a non-stick coating are recommended to enhance the free flow of particles in solution. Particles may adhere to uncoated rubber stoppers, rendering the standard unreliable. Stoppers with elaborate 3D structures, such as those used for lyophilized products, may also trap particles. 

Q: How many particles can be inserted into each standard? 

A: Typically, blank or single particle standards are fabricated. Upon request, two or three particles per container can be added to your order. Requests for more than 3 particles will be handled on a case-by-case basis. 

Q: What is the smallest available particle size? 

A: Our qualified technicians can insert particles as small as 100 microns for use in automated inspection machine validation. 

Particle Validation Standards less than 100 microns may adhere to rubber stoppers or wedge between stoppers/plungers and the glass of the container. 

The minimum size we manufacture for validation of human inspectors is typically 100-200µm depending on the particle type. 

Q: What are the criteria for determining the ideal particle color? 

A: Automated inspection machines are usually equipped with black and white cameras and human inspectors cannot detect color differences in small particles. As such, particle color may not be critical for your process. However, your particle validation standards should be representative of contaminants that are clear and opaque, reflective and non-reflective, light and heavy, bright and dark in color and of different shapes. 

Q: Is bacteriostatic water the best fluid fill? 

A: Bacteriostatic water is the traditional fluid fill except when the usual product fill is significantly different in viscosity or turbidity. In these cases, Particle Validation Standards may be created with your product (A Safety Data Sheet is required prior to quoting). 

Q: Can fluid degrade or discolor the particle standard; can particle standards affect the fluid? 

A: It is very rare to have any reaction between the particle and the standard bacteriostatic fill solution.   

Q: Are Quality Certificates available for every order? 

A: A Certificate of Compliance and Traceability is included with each order at no extra charge. This Certificate states that particle sizing is conducted with measuring instruments traceable to the National Institute of Standards and Technology (NIST) and that the standards are made in accordance with ISO 9001: current version Quality System guidelines. 

Q: Is there a minimum quantity per order? 

A: There is a minimum order by particle type and size.  

Q: How are particle standards labeled? 

A: Containers are provided unmarked and a key is provided in your partitioned validation standards kit which identifies particle size, type, etc., by compartment. 

Other labeling considerations include fluorescent or black ink marking. 

Q: Is there an expiration date on the particle standard? 

A: The certificate for each lot typically has a two-year expiration date. Depending on fill solution and particle type the expiration may vary. 

Q: How are remnants of customer supplied components handled after an order is fabricated? 

A: All drug products and syringes are returned to the Customer. Extra glassware and other supplies are disposed of or recycled, unless prior arrangements are made. Returned items will incur a separate handling fee and standard shipping charges. 

Q: Can orders be received in partial shipments? 

A: Partial shipments can be made but will incur a separate handling fee to cover the administrative costs of multiple shipments. Standard shipping costs will also apply to each shipment. 

Q: What is the typical lead time? 

A: This will depend on the project specifics such as quantity ordered, particle sizes, and resource availability. Lead times are custom quoted for each project. 

Q: How often should automatic inspection machines be validated? 

A: Automated visual systems should be validated using the recommendations of the machine manufacturer or after any adjustments or modifications have been made to the system. 

Q: What can cause a false positive? 

A: A false positive reading is possible in cases such as bubbles in the fluid, irregular light beams that cause reflections, if the bottom of the product container is irregularly shaped or if an automated visual inspection system is set for high sensitivity. 

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