Millistak+® Pod Disposable Depth Filter Systems
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Material Qualification Dossier
| Título | Versão |
|---|---|
| 3.0 |
Referências
| Visão geral das referências |
|---|
| Einzigartiges Einwegfiltrationskonzept (Unique Disposable Filter Concept) Estelle Zelter, Clarification and Prefiltration Technology Manager in Molsheim, France GIT-Laborfachzeitschrift (German), Issue May 2006 GIT SPECIAL Separation (German), issue September 2006 2006 |
| A Fully Disposable Monoclonal Antibody Manufacturing Train J.S. Wilson RP1019EN00 2006 Mostrar Resumo Celliance Ltd. has been manufacturing monoclonal antibodies (MAbs) for the diagnostics industry for over 20 years. It first adopted a disposable approach to continuous fermentor harvest collection in 1991. However, all other aspects of the manufacturing process were based on traditional processing systems and therefore dependent on clean-in-place (CIP) and steam-in-place (SIP) systems, with the concomitant expense of ongoing maintenance and validation. Over the years regulatory pressure has increased, making introducing new products into an FDA-approved multiproduct facility an expensive and time-consuming process. Discussions with regulators indicated that using dedicated equipment was an acceptable method for product control and risk reduction, but a far superior method would be transitioning to fully disposable systems wherever possible. |
| "Les bonnes pratiques de la transposition d'échelle" (Good Practices for Scale Up) Estelle Zelter, Clarification & Prefiltration Technology Manager Europe Steve Vermant, TFF Expandable Technology Manager Europe Industrie Pharma (French journal), issue 16/2005, September 2005, pages 44-45 2005 |
| "Schneller und effizienter" (Faster and more efficient) Ulrich Hoebel, Key Account Manager for Boehringer Ingelheim & Regional Sales Manager in Central Area Biotechnica Today, official journal of the Hannover tradeshow Biotechnica, published by the German magazine Laborpraxis, issue October 18 2005, page 9 2005 |
| Impact of Design and Selection of Prefilters on Operating Cost Honig, Ephraim S., and Perry D. Schwartz; Filtration & Separation (Jan/Feb 1997). Filtration & Separation (Jan/Feb 1997). 1997 |
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Description
Millistak+® depth filter media is offered in a scalable, disposable format, the Pod Filter System. Accommodating applications from lab to pilot to process scale, the Pod format offers greater flexibility because of its unique modular design.
The Millistak+® Pod system is ideal for a wide variety of primary and secondary clarification applications, including cell cultures, yeast and E. coli lysates post centrifuge, E. coli refolds, media, vaccines, plasma proteins and sera.
Millistak+® Pod filters are available in three distinct series of media grades in order to meet your specific application needs. Millistak+® DE, CE and HC media deliver optimal performance through a gradient density matrix as well as positive surface charge properties.
Benefits
- Low hold-up volume for greater product yield
- Broad range of media types offered in single and multilayer products
- Millistak+® HC dual-action media improves prefiltration and compresses clarification
- Flexible, modular format offers scalability from 5 to 12,000 liters or more
- Patented disposable design eliminates need for housing, CIP or cleaning validation
- Self-contained Pod filters protect operators from exposure to biohazards
- Robust construction is easy to use and set up
- Smaller footprint facilitates use in tight spaces
Easy to Use
With the compact, modular design of our Millistak+® new Pod system, you can increase productivity and shorten cycle times.
Installation and setup of the Pod system is simple and straightforward. The unique design of the disposable adapters and disposable manifolds makes it easy to connect the Pod filters to rest of the unit operations in the process. The self-contained and disposable nature of the system protects operators from exposure to biohazards and eliminates maintenance as well as cleaning validation requirements.
Configurations
- μPod filter – 23 cm2
- Lab scale Pod – 0.027 m2, 0.054 m2
- Millistak+® DE and CE media — 0.11 m2, 0.77 m2, or 1.4 m2 filtration area.
- Millistak+® HC media — 0.11, 0.55, or 1.1 m2 filtration area.
- Pilot scale holder — accommodates up to two full-size Pod filters for configurations from 0.11 m2 to 2.8 m2 depending on media type. An optional accessory kit expands capacity to five full scale Pod filters.
- Process scale holder — accepts from five to ten Pod filters per rack. Up to three racks can be stacked for process flexibility.
- Disposable adapters — connects Pod filters to process piping, creating a disposable flow path.
- Disposable diverter plates — enables more than one media grade on a single rack
Millistak+® Depth Filter Media
Available in three media series, the proven filtration performance of Millistak+® filter media in the Pod format provides greater flexibility and reduced cycle times. Millistak+® Pod filters incorporate multiple graded-density layers and adsorptive, positively-charged filter media. Composed of select grade cellulose fiber and diatomaceous earth, the Millistak+® DE series not only improves the manufacturing process but also increases contaminant holding. In addition, the Millistak+® CE series consists of single-layer media with cellulose fibers that are suitable for coarse filtration applications.
The Millistak+® HC series improves productivity by combining multiple media grades into one device, enabling compression of multiple filtration stages downstream of the bipreactor.
| Choose the Right Media | ||
| Select your media grade based upon the specific process particle loading requirements and the downstream filter being protected. | ||
| Media Grade | Application* | Characteristics |
| Triple-layer A1HC | Post-TFF (Prostak™) clarification fluids | Triple layer tight media combination of DE60, DE75 and an additional RW01 membrane layer (0.1 µm) to protect downstream membrane filters |
| Triple-layer B1HC | Secondary clarification post tangential flow filtration, or depth filtration or centrifugation |
Triple layer open media combination of DE50, DE75 and an additional RW01 membrane layer (0.1 µm) to protect downstream membrane filters |
| Double-layer C0HC | Primary clarification. In some cases, can be used as a single stage clarification step going directly into a sterile filter |
Double layer open media combination with DE30 + DE60 |
| Single-layer CE | Primary (coarse) clarification | Cellulose fibers |
| Double-layer D0HC | Primary clarification | Double layer open media combination with CE25 + DE40 |
| Single-layer DE | Primary or secondary clarification | Cellulose fiber and diatomaceous earth |
| Double-layer F0HC | Secondary clarification post–centrifugation or pre-treated centrate | Double layer tight media combination of DE layers DE60 + IM75 |
| Double-layer X0HC | Secondary clarification post depth filtration or centrifugation. Can also be utilized in downstream processing steps to protect chromatography columns. | Double layer tight media combination of DE layers IM75 + IM83 |
| *For clarification of serum, plasma, vaccines or other fluids, choice of media grade should be based on small-scale trials. | ||
Bulk Packaging
To improve sustainability of the packaging and shipping of filter products, we have developed a bulk pack solution for Millistak+® Multilayer 1.1m2 Pods with the aim to optimize transport and reception processes as well as to reduce waste. Bulk packaging configuration includes 27 Pods in 3 boxes with 9 Pods per layer on 1 pallet.
The key benefits are:
- 24% reduction in corrugated packaging waste to recycle or dispose
- 94% reduction of paper documentation
- 12% decrease in number of deliveries which will further reduce energy use and emissions
- 70% reduction in operator time to open and manage the product and packaging
| Dimensions | |||
| Length, cm (in.) | 62 (24.2) | 62 (24.2) | 62 (24.2) |
| Height, cm (in.) | 32 (12.5) | 32 (12.5) | 32 (12.5) |
| Thickness, cm (in.) | 3 (1.2) | 7.1 (2.8) | 12.2 (4.8) |
| Materials of Construction | |||
| Filter Media/Membrane (grades A1HC and B1HC) |
Cellulose (CL) Inorganic Filter Aid Mixed Cellulose Esters (MCE) |
Cellulose (CL) Inorganic Filter Aid Mixed Cellulose Esters (MCE) |
Cellulose (CL) Inorganic Filter Aid Mixed Cellulose Esters (MCE) |
| Filter Media | Cellulose (CL) Inorganic Filter Aid |
Cellulose (CL) Inorganic Filter Aid |
Cellulose (CL) Inorganic Filter Aid |
| Maximum Inlet Pressure, bar (psi) | 3.5 bar (50 psi) @ 25 °C; 1 bar (15 psi) @ 80 °C | ||
| Maximum Differential Pressure, bar (psi) | Forward: 2.1 bar (30 psid) @ 25 °C; 1 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C | ||
| Sterilization | 1 autoclave cycle of 60 min @ 123 °C | ||
| Bacterial Endotoxin | For Media Only: < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. | ||
| Toxicity | All component materials meet the requirements of the current USP <88> Biological Reactivity Test For Class VI Plastics. | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Pressure Equipment Directive 2014/68/EU | This filter has been designed and manufactured according to the essential requirements of the Pressure Equipment Directive 97/23/EC. Only 1 m2 filters carry the CE mark. | ||
| Typical Extractables | |||
| NVR Gravimetric Extractables | After 24 hour static soak in pure water (Type 1 DI Water) post autoclave (1 cycle of 60 minutes at 123 °C) and pure water flush of 100 L/m2 of media surface area: 39 – 69 mg/m2 | ||
| Conductivity | 8.66 – 10.5 µS/cm post autoclave (1 cycle of 60 minutes at 123 °C) and pure water flush of 100 L/m2 (10 L/ft2) of media surface area | ||
| TOC | 720 – 1260 ppb post autoclave (1 cycle of 60 minutes at 123 °C) and pure water flush of 100 L/m2 (10 L/ft2) of media surface area | ||
| Metals | Per 24 hour soak in 10 L pure water post autoclave (1 cycle of 60 minutes at 123 °C) and pure water flush of 100 L/m2 (10 L/ft2) of media surface area: | ||
| Sodium: <3.0 mg/ft2 Calcium: <0.7 mg/ft2 Magnesium: <0.2 mg/ft2 Mercury: <0.01 mg/ft2 Chromium: <0.01 mg/ft2 Aluminum: <0.01 mg/ft2 Potassium: <0.01 mg/ft22 Lead: <0.01 mg/ft2 Arsenic:<0.01 mg/ft2 Cobalt: <.01 mg/ft2 Iron:<0.01 mg/ft2 Manganese: <0.01 mg/ft2 Titanium: <.01 mg/ft2 Zinc: <0.01 mg/ft2 |
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Water Permeability
Grade A1HC Pod Filters
Grade B1HC Pod Filters
Grade C0HC Pod Filters
Grade D0HC Pod Filters