Durapore® 0.1 µm and 0.22 µm Cartridge Filters
A trusted name in the industry for over 25 years, The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.
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A trusted name in the industry for over 25 years, The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties. Less
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Overview
Specifications
Ordering Information
Documentation
Material Qualification Dossier
| Title | Version |
|---|---|
| 1.0 |
Quality Management Dossier (Open Access)
| Title |
|---|
Operational Excellence Dossier
| Title |
|---|
Technical Info
References
| Reference overview |
|---|
| Evaluation of Recovery Filters for Use in Bacterial Retention Testing of Sterilizing-Grade Filters Carter, Jeff; Vol. 50, No.3 / May-June Vol. 50, No.3 / May-June 1996 |
FAQ
| Question | Answer |
|---|---|
| Can Durapore 0.22 micron cartridges be used in the reverse direction? | Durapore filters are bidirectionally supported. If the filter is inadvertently used in the reverse direction, a post-use integrity test will identify whether or not the filter cartridge was integral during processing. The specification for theis filter is > 50.0 psi for a water bubble point test and < 13.3 ml/minute per 10"element for a diffusion test. If the filter passes this test, no damage occured during use. Please note that the maximum allowable pressure specification is different in the reverse direction - 50 psid vs. 80 psid in the forward direction. |
| What are the most common causes of filter clogging (air bubbles, particulates, surface tension, inappropriate filter size etc.)? | Trapped bubbles, particulates and improper sizing are all common causes of fitration issues. True filter clogging is caused by particulates. Hard particles will form a cake on the filter surface. This will generally slow the filtration but not necessarily block filtration becuase fluid can flow through the layer of hard particles and then through the filter. Deformable particles can compress across the filter pores, forming impermeable barriers to filtration. This type of problem is common with solutions containing proteins or lipids. |
| What is the compatibility of Durapore with high pH solutions? | The upper recommended pH limit for Durapore membranes is 10. At pH >10, the hydrophilization layer of the membrane may become subject to hydrolysis. The extent of hydrolysis is a function of time, temperature , concentration and time of exposure. Upon exposure to high pH, the hydrophylization layer can swell which could result in a loss of permeability or flux. The hydrolysis of the hydrophilic layer will also lead to increased extractables from the membrane. |
| What are Millipore's general recommendations for filtering high pH solutions? | For applications involving pH > 10, Millipore recommends the use or our PES membranes Express SHF or Express SHC. For information on these filters : Express SHF: http://www.millipore.com/catalogue.nsf/docs/C8873 Express SHC: http://www.millipore.com/catalogue.nsf/docs/C9146 |
| How can I differentiate filter plugging due to air bubbles, particulates, surface tension, inappropriate filter size, etc.? | Air locking will occur when filtration is initiated without adequate venting or when air bubbles become trapped in fluid lines. Air will pass easily through a dry hydrophillic or hydrophobic filter. However, when a filter is wet and air is applied to a surface, the air will remain until it is manually moved upstream by venting or until the bubble point of the filter is reached. Bubble point is defined as the pressure at which gas displaces liquid for the largest set of filter pores and is able to flow through the pores. Air locking reduces the effective filtration area of the filter and thus reduces the flow rate. Surface tension refers to the strong cohesive forces present between molecules at the surface of a liquid. The higher the surface tension, the more force is required to force fluid through the membrane.. Innapropriate filter size will can cause a filter to plug prematurely. Filter pore size is chosen based on the application. If the application requires a sterile fluid, than a 0.22 micron membrane would be used for standard solutions that have bacterial bioburden. A 0.1 micron filter would be used for applications where mycoplasma is a concern. Where virus contamination is a concern, ultrafiltration would be required. The selection of a filter pore size that is smaller than that required for the application will cause a decrease in filter capacity and an increase in cost. |
User Guides
| Title |
|---|
| Hydrophilic Durapore® Cartridges and Capsules User Guide |
Related Products & Applications
Product Families
OptiScale® Capsule Filters for Aseptic Processing ApplicationsOptiScale® capsules, with a large variety of filtration media options, are a family of convenient, disposable filters ideal for media selection, process screening and scaling.Learn More >> |
Durapore® 0.1 µm and 0.22 µm Gamma Compatible Capsule FiltersEnhanced process efficiency and cost-effectiveness from reduced cleaning and validation requirementsLearn More >> |
Durapore® 0.1 µm and 0.22 µm Capsule FiltersSterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs.Learn More >> |
Durapore® Membrane in Millidisk® Cartridge FiltersDesigned for the removal of particles and microorganisms from liquids and gases.Learn More >> |
Durapore® 0.1 µm and 0.22 µm Capsule FiltersSterile Opticap capsule filters are fully contained capsule filters with Durapore 0.22 µm or 0.1 µm hydrophilic PVDF membrane.Learn More >> |
Durapore® 0.1 µm and 0.22 µm Optiseal® Cartridge FiltersOptiseal cartridge filters feature a revolutionary cartridge-to-housing sealing mechanism and pleated configuration, resulting in maximum sterility assurance and economical performance.Learn More >> |
Related Products By: Application Facete
| Antibody Purification |
| Dialysis and Filtration |
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| Durapore® |
Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore |
Description
A trusted name in the industry for over 25 years, Durapore® sterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding* and provide sterility assurance, high flow rates and throughputs. The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.
Hydrophilic Durapore cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles. Each Durapore cartridge filter is integrity tested during the manufacturing process.
* For information on Durapore protein binding, call MilliporeSigma Technical Service and request Reprint No. RP260.
Regulatory Compliance
Filters with hydrophilic Durapore membrane are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each device is marked with the product name and identifying characteristics.
Multiple Formats Available
A full range of filtration areas is available to suit varying application requirements and a variety of connection options are offered to meet your application and housing requirements.
The Emprove® Program
The Emprove® Program complements the product portfolio through
- Comprehensive documentation to support qualification, risk assessment and process optimization needs.
- Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
- Convenient 24/7 access to up-to-date product information.
| OptiScale & Millipak Capsules | ||||
| OptiScale 25 | OptiScale 47 | Millipak 100 | Millipak 200 | |
| Nominal Dimensions | ||||
| Maximum length: | 39 mm (1.52 in.) with female Luer-Lok inlet/male Luer-Lok outlet | 82 mm (3.24 in.) with flange inlet/hose barb outlet; 74 mm (2.91 in.) with flange inlet/flange outlet; 94 mm (3.70 in.) with hose barb inlet/hose barb outlet |
11 cm (4.2 in.) 13 cm (5.1 in.) |
13 cm (5.1 in.) 15.5 cm (6.1 in.) |
| Body diameter: | 31 mm (1.21 in.) | 69 mm (2.75 in) | 76 cm (3.0 in.) | |
| Weight: | 0.19 oz (5.5 g) | 2.3 oz (67 g) | — | |
| Filtration Area | 3.5 cm² | 17.7 cm² | 500 cm² (0.54 ft²) | 1000 cm² (1.08 ft²) |
| Materials of Construction | ||||
| Filter membrane: | Hydrophilic PVDF | |||
| Structural components: | Polypropylene | Polycarbonate | ||
| Supports: | Polypropylene | Polycarbonate | ||
| Vent caps: | Polypropylene | PVDF | ||
| Internal seal rings: | Fluoroelastomers | — | ||
| Housing Vent | Capped vent with female Luer connections on inlet side of device. | Adjustable vent with male Luer and female Luer-Lok connections on inlet side of device. | ||
| Maximum Inlet Pressure | 4.1 bar (60 psi) at 25 °C | 5.5 bar (80 psi) at 25 °C | 5.2 bar (75 psi) at 25 °C | |
| Maximum Differential Pressure | ||||
| Forward: | 4.1 bar (60 psi) at 25 °C | — | 4.1 bar (60 psid) at 25 °C 1.7 bar (25 psid) at 80 °C 345 mbar (5 psid) at 123 °C |
|
| Reverse: | 0 bar (0 psi) | — | 690 mbar (10 psid) at 25 °C | |
| Bubble Point at 23 °C | ||||
| 0.1 μm: | — | — | ≥ 4830 mbar (70.0 psig) air with water | |
| 0.22 μm: | — | — | ≥ 3450 mbar (50.0 psig) air with water | |
| NVR Gravimetric Extractables | — | — | After autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature: | |
| ≤ 2.5 mg | ≤ 5.0 mg | |||
| Oxidizable Substances | — | Meets the requirements of the USP Oxidizable Substance for Sterile Water for Filtration Test after a water flush of: | ||
| ≤ 100 mL. | 200 mL | |||
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | — | Aqueous extraction contains < 0.5 EU mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | |
| Bacterial Retention | — | — | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology. | |
| TOC Conductivity | This product exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS per USP <645> after autoclave and WFI water flush of 35 mL. | — | — | |
| Sterilization | May be autoclaved for 1 cycle of 60 minutes at 123 °C | May be autoclaved for 3 cycles of 60 minutes at 126 °C | May be autoclaved for 3 cycles of 90 minutes at 123 °C. Capable of 45 kilogray (4.5 Megarad) gamma exposure (cannot be steam sterilized in-line). | |
| Good Manufacturing Practices | These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices. | |||
| Non-Fiber Releasing | Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | |||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters meet the requirements of the current USP <88> Safety Test. | |||
| Indirect Food Additive | Durapore membrane meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182. | |||
| Opticap XL Caps Autoclavable | ||||
| Opticap XL 2 | Opticap XL 4 | Opticap XL 5 | Opticap XL 10 | |
| Nominal Dimensions | ||||
| Maximum length: | 14.2 cm (5.6 in.) | 19.6 cm (7.7 in.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) |
| Body diameter: | 8.4 cm (3.3 in.) | 10.7 cm (4.2 in.) | ||
| Filtration Area | 0.09 m² (0.93 ft²) | 0.19 m² (2.09 ft²) | 0.35 m² (3.7 ft²) | 0.69 m² (7.4 ft²) |
| Materials of Construction | ||||
| Filter membrane: | Hydrophilic PVDF | |||
| Film edge: | Polypropylene | |||
| Supports: | Polypropylene | |||
| Structural components*: | Polypropylene | |||
| Vent O-rings: | Silicone | |||
| Vent/Drain | ¼ in. hose barb with double O-ring seal | |||
| Maximum Inlet Pressure | 5.5 bar (80 psi) at 23 °C 2. 8 bar (40 psi) at 60 °C 1.0 bar (15 psi) at 80 °C |
|||
| Maximum Differential Pressure | ||||
| Forward: | 5.5 bar (80 psid) at 25 °C, 1.0 bar (15 psid) at 80 °C | |||
| Reverse: | 3.4 bar (50 psid) at 25 °C, intermittent | |||
| Bubble Point at 23 °C | ||||
| 0.1 μm: | ≥ 4830 mbar (70.0 psig) air with water | |||
| 0.22 μm: | ≥ 3450 mbar (50.0 psig) air with water | |||
| Air Diffusion | Through a water wet membrane at ambient temperature: | |||
| 0.1 μm at 3.9 bar (56 psig): | — | ≤ 7.5 cc/min | ≤ 10.0 cc/min | ≤≤ 20.0≤ cc/min |
| 0.22 μm of 2.8 bar (40 psig): | — | ≤ 5.5 cc/min | ≤ 6.6 cc/min | ≤≤ 13.3≤ cc/min |
| Oxidizable Substances | Meets the requirements of the USP Oxidizable Substances Test after a water flush of: | |||
| 500 mL | 1000 mL | |||
| Bacterial Endotoxin | Aqueous extraction contains | |||
| Bacterial Retention | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology. | |||
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line). | |||
| Good Manufacturing Practices | These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices. | |||
| Non-Fiber Releasing | Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | |||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters meet the requirements of the current USP <88> Safety Test. | |||
| Indirect Food Additive | The Durapore membrane used in these products meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182. | |||
| * Cage, core, end caps and capsule housing. | ||||
| Opticap XLT Capsules Autoclavable | |||
| Opticap XLT 10 | Opticap XLT 20 | Opticap XLT 30 | |
| Nominal Dimensions | |||
| Maximum length: | 37.6 cm (14.8 in.) | 62.5 cm (24.6 in.) | 87.1 cm (34.3 in.) |
| Fitting to Fitting | |||
| Sanitary flange to sanitary flange: | 15.2 cm (6.0 in.) | ||
| Sanitary flange to hose barb: | 17.5 cm (6.9 in.) | ||
| Hose barb to hose barb: | 19.8 cm (7.8 in.) | ||
| Filtration Area | 0.69 m² (7.4 ft²) | 1.4 m² (14.8 ft²) | 2.1 m² (22.2 ft²) |
| Materials of Construction | |||
| Filter membrane: | Hydrophilic PVDF | ||
| Film edge: | Polypropylene | ||
| Supports: | Polypropylene | ||
| Structural components*: | Polypropylene | ||
| Vent O-rings: | Silicone | ||
| Maximum Inlet Pressure | 5.5 bar (80 psi) at 23 °C 2.8 bar (40 psi) at 60 °C 1.0 bar (15 psi) at 80 °C |
||
| Maximum Differential Pressure | |||
| Forward: | 5.5 bar (80 psid) at 25 °C, 1.7 bar (25 psid) at 80 °C | ||
| Reverse: | 3.5 bar (50 psid) at 25 °C, intermittent | ||
| Bubble Point at 23 °C | |||
| 0.1 μm: | ≥ 4830 mbar (70.0 psig) air with water | ||
| 0.22 μm: | ≥ 3450 mbar (50.0 psig) air with water | ||
| Air Diffusion | Through a water wet membrane at ambient temperature: | ||
| 0.1 μm at 3.9 bar (56 psig): | ≤ 20.0 cc/min | ≤ 40.0 cc/min | ≤ 60.0 cc/min |
| 0.22 μm of 2.8 bar (40 psig): | ≤ 13.3 cc/min | ≤ 26.6 cc/min | ≤ 39.9 cc/min |
| Oxidizable Substances | Meets the requirements of the USP Oxidizable Substances Test after a water flush of: | ||
| ≤ 1000 mL | ≤ 2000 mL | ≤ 3000 mL | |
| Bacterial Endotoxin | Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||
| Bacterial Retention | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology. | ||
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line). | ||
| Good Manufacturing Practices | These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices. | ||
| Non-Fiber Releasing | Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | ||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters meet the requirements of the current USP <88> Safety Test. | ||
| Indirect Food Additive | The Durapore membrane used in these products meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182. | ||
| * Cage, core, end caps and capsule housing. | |||
| Cartridge Filters Autoclavable | ||
| 5-inch Cartridge | Per 10-inch Cartridge | |
| Nominal Dimensions | ||
| Outside diameter: | 6.9 cm (2.7 in.) | |
| Filtration Area | 0.35 m² (3.7 ft²) | 0.69 m² (7.4 ft²) |
| Materials of Construction | ||
| Filter membrane: | Hydrophilic PVDF | |
| Film edge: | Polypropylene | |
| Supports: | Polypropylene | |
| Structural components: | Polypropylene | |
| O-rings: | Silicone | |
| Maximum Differential Pressure | ||
| Forward: | 5.5 bar (80 psid) at 25 °C, 1.8 bar (25 psid) at 80 °C, 345 mbar (5 psid) at 135 °C |
|
| Reverse: | 3.4 bar (50 psid) at 25 °C, intermittent | |
| Bubble Point at 23 °C | ||
| 0.1 μm: | ≥ 4830 mbar (70.0 psig) air with water | |
| 0.22 μm: | ≥ 3450 mbar (50.0 psig) air with water | |
| Air Diffusion | Through a water wet membrane at ambient temperature: | |
| 0.1 μm at 3.9 bar (56 psig): | ≤ 20.0 cc/min per 10-inch element | |
| 0.22 μm of 2.8 bar (40 psig): | ≤ 13.3 cc/min per 10-inch element | |
| Oxidizable Substances | Meets the requirements of the USP Oxidizable Substances Test after a water flush of: | |
| ≤ 1000 mL per 10-inch element | ||
| Bacterial Endotoxin | Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | |
| Bacterial Retention | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology. | |
| Sterilization | May be autoclaved for 30 cycles of 60 minutes at 126 °C or steam sterilized up to 30 times for 30 minutes at 135 °C. | |
| Good Manufacturing Practices | These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices. | |
| Non-Fiber Releasing | Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | |
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters meet the requirements of the current USP <88> Safety Test. | |
| Indirect Food Additive | The Durapore membrane used in these products meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182. | |
| Opticap XL and XLT Capsules (Gamma Compatible) | ||||
| Opticap XL 10 | Opticap XLT 10 | Opticap XLT 20 | Opticap XLT 30 | |
| Nominal Dimensions | ||||
| Maximum length: | 33.5 cm (13.2 in.) | 37.6 cm (14.8 in.) | 62.5 cm (24.6 in.) | 87.1 cm (34.3 in.) |
| Body diameter: | 10.7 cm (4.2 in.) | |||
| Fitting to Fitting | ||||
| Sanitary flange to sanitary flange: | — | 15.2 cm (6.0 in.) | ||
| Sanitary flange to hose barb: | — | 17.5 cm (6.9 in.) | ||
| Hose barb to hose barb: | — | 19.8 cm (7.8 in.) | ||
| Filtration Area | 0.73 m² (7.8 ft²) | 1.45 m² (15.6 ft²) | 2.17 m² (23.4 ft²) | |
| Materials of Construction | ||||
| Filter membrane: | Hydrophilic PVDF | |||
| Film edge: | Polyethylene | |||
| Supports: | Polyester | |||
| Structural components*: | Gamma Stable Polypropylene | |||
| Vent O-rings: | Silicone | |||
| Vent/Drain | ¼ in. hose barb with double O-ring seal | |||
| Maximum Inlet Pressure | 5.5 bar (80 psi) at 23 °C 2.8 bar (40 psi) at 60 °C 1.0 bar (15 psi) at 80 °C |
|||
| Maximum Differential Pressure | ||||
| Forward: | 5.5 bar (80 psid) at 25 °C, 1.7 bar (25 psid) at 80 °C | |||
| Reverse: | 3.5 bar (50 psid) at 25 °C, intermittent | |||
| Bubble Point at 23 °C | ||||
| 0.1 μm: | ≥ 4830 mbar (70.0 psig) air with water | |||
| 0.22 μm: | ≥ 3450 mbar (50.0 psig) air with water | |||
| Air Diffusion | Through a water wet membrane at ambient temperature: | |||
| 0.1 μm at 3.9 bar (56 psig): | ≤ 21.1 cc/min | ≤ 42.2 cc/min | ≤ 63.3 cc/min | |
| 0.22 μm of 2.8 bar (40 psig): | ≤ 14.0 cc/min | ≤ 28.0 cc/min | ≤ 42.0 cc/min | |
| NVR Gravimetric Extractables | After autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature: | |||
| ≤ 25 mg | ≤ 50 mg | ≤ 75 mg | ||
| Oxidizable Substances | Meets the requirements of the USP Oxidizable Substances Test after a water flush of: | |||
| 1000 mL | 2000 mL | 3000 mL | ||
| Bacterial Endotoxin | Aqueous extraction contains | |||
| Bacterial Retention | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology. | |||
| Sterilization | Gamma compatible to 45 kGy. May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line). | |||
| Good Manufacturing Practices | These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices. | |||
| Non-Fiber Releasing | Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | |||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters meet the requirements of the current USP <88> Safety Test. | |||
| Indirect Food Additive | The Durapore membrane used in these products meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182. | |||
| * Cage, core, end caps and capsule housing. | ||||