This notice was originally sent on July 1st, and most recently updated on August 14th, 2025. |
Dear Hardy Diagnostics Customer,
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Thank you for your loyalty to Hardy Diagnostics. As part of our continuous improvement efforts, we have made strategic investments to enhance our irradiated plate line manufactured at our Springboro, OH facility. The implementation of these changes is planned to be fully implemented by October 1, 2025. |
What to expect from the improvement activities: |
- New part numbers will replace current part numbers. See Table 1 for a change matrix. Current part numbers will be discontinued. Note: price agreements are being updated to include the new part numbers. Your active pricing will remain valid through current price agreements.
- Plate packaging is optimized for automation.
- The first wrap is a breathable film, eliminating the need for a desiccant.
- Sterile sample bags are no longer included. They can be purchased separately (Part no. BAS381BX).
- All wraps use transparent (clear) packaging films.
- Labeling consists of a single irradiation indicator label on the inner wrap.
- Plates are triple wrapped prior to irradiation, which includes a removable outer wrap. Follow your internal procedures for cleanroom use. Remove the outer wrap prior to cleanroom entry.
- Plate media fill is optimized for automation and compatible with continuous monitoring activities.*
- Product changes have passed internal product validation studies and are deemed equivalent to existing part numbers.
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For more details on these changes, along with features and benefits, please see Table 2 and the product illustrations below. We are confident these changes will improve product quality. Based on the nature of the change, this is classified as a major change. Please update your documentation accordingly. |
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Purchase orders require your prompt attention: |
- Purchase orders for existing parts submitted through non-scheduled agreements must be submitted by September 1, 2025. Please contact our Customer Service team.
- Purchase orders on scheduled agreements of current parts will be stocked and shipped according to assigned dates up to September 30, 2025. After this date, agreements require new part numbers by ship date. Please contact our Standing Order team.
- Continued support is available through your local Hardy Diagnostics Account Manager, Customer Service Team, Standing Order, and Technical Services teams.
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Customers affected by product revalidation: |
- Submit a Customer Response Form (attached) no later than August 1, 2025.
- Response forms must include:
- All part numbers required.
- The number of lots required for each part number.
- The quantity of plates required from each part and/or lot. Note: Products are sold in packages of 10 plates. Orders must correspond with this unit of measure.
- Customer contact information.
- Purchase orders for validation lots must be placed with Customer Service. Customer Service will provide a lead time at the time of PO receipt.
- Please place orders for existing part numbers now to meet your needs until the change has been fully implemented.
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We sincerely appreciate your continued use of Hardy Diagnostics’ products and look forward to assisting you with this change. Sincerely, |
Christopher Catani
Chief Executive Officer |
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Table 1: Cross reference of current and new Hardy Diagnostics part numbers. |
| Current Hardy Part no. | New Hardy Part no. | New Part no. Description | Current Part no. to be Discontinued | Packaging Improvement | Fill Change |
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| P520 | P365 | Tryptic Soy Agar (Soybean Casein Digest Agar), with Lecithin and Tween® 80, USP, Lok-Tight™, irradiated, triple bagged, contact plate with friction lid and optional locking feature, PK10 plates | ✓ | ✓ | N/A | | P520R | P365R | Tryptic Soy Agar (Soybean Casein Digest Agar), with Lecithin and Tween® 80, USP, Lok-Tight™, irradiated, triple bagged, red tint contact plate with optional locking feature, PK10 plates | ✓ | ✓ | N/A | | P580 | N/A | N/A | ✓ | N/A | N/A | | P595 | P385 | SabDex (Sabouraud Dextrose) Agar with Lecithin and Tween® 80, USP, Lok-Tight™, irradiated, triple bagged, contact plate with friction lid and optional locking feature, PK10 plates | ✓ | ✓ | N/A | | W520 | W365 | Tryptic Soy Agar (Soybean Casein Digest Agar), with Lecithin and Tween® 80, USP, SterEM™, irradiated, triple bagged, 15x100mm plate, 26ml fill, PK10 plates | ✓ | ✓ | N/A | | W530 | W390 | R2A Agar, SterEM™, irradiated, triple bagged, 15x100mm plate, 26ml fill, PK10 plates | ✓ | ✓ | N/A | | W540 | W340 | Tryptic Soy Agar (Soybean Casein Digest Agar), USP, SterEM™, irradiated, triple bagged, 15x100mm plate, 26ml fill, PK10 plates | ✓ | ✓ | ✓ | | W540R | W340R | Tryptic Soy Agar (Soybean Casein Digest Agar), USP, SterEM™, irradiated, triple bagged, red tint 15x100mm plate, 26ml fill, PK10 plates | ✓ | ✓ | ✓ | | W565 | W370 | SabDex (Sabouraud Dextrose) Agar, USP, SterEM™, irradiated, triple bagged, 15x100mm plate, 26ml fill, PK10 plates | ✓ | ✓ | N/A | | W570 | W340 | Tryptic Soy Agar (Soybean Casein Digest Agar), USP, SterEM™, irradiated, triple bagged, 15x100mm plate, 26ml fill, PK10 plates | ✓ | ✓ | N/A | | W570R | W340R | Tryptic Soy Agar (Soybean Casein Digest Agar), USP, SterEM™, irradiated, triple bagged, red tint 15x100mm plate, 26ml fill, PK10 plates | ✓ | ✓ | N/A | | W595 | W385 | SabDex (Sabouraud Dextrose) Agar with Lecithin and Tween® 80, USP, SterEM™, Irradiated, Triple Bagged, 15x100mm plate, 26ml fill, PK10 plates
| ✓ | ✓ | ✓ |
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Table 2: Features and benefits of new improved part numbers |
| Feature | Benefit |
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| Breathable transparent inner wrap | Desiccant eliminated; maintains optimal media moisture content | | PET layer for middle and outer wraps | Transparent, low permeability film material for extended shelf life
| | Permanent irradiation indicator label | Sterility assurance and quality assurance | | Standardized plate fills | Manufacturing efficiency; compatibility with continuous active monitoring activities* | | 15-30°C storage | Efficient ambient temperature storage | | 10-6 Sterility Assurance Level (SAL) | Sterility assurance and quality assurance | | Dust barrier wrap | Outer wrap can be removed prior to entry into a cleanroom/ECA eliminating the need for disinfection before use | | Traditional clear and red-tint plates | Rapid formulation differentiation | | LokTight™ contact plates | Friction and optional locking lid, for greater security after sampling | | Superior quality | Reliable/repeatable results | | Large single lot sizes | Cost savings | | Nationwide distribution center stocking | Reduced shipping fees; faster order service |
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*Must be validated by the end user. Hardy Diagnostics does not collect data on the efficacy of user-specific validated procedures. |
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The current design is depicted here: |
| The improved design is depicted here: |
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Customer Response Form – Irradiated Plates Validation Request |
Please list requirements in this form and include Customer Contact Information. Forms must be returned via email to LewisC@HardyDiagnostics.com and GarzaK@HardyDiagnostics.com by
August 1, 2025 for us to prepare validation lots. Please place purchase orders for validation lots of the new part numbers with Customer Service through our Special Order process. |
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Thank you for allowing us to provide you with
a Culture of Service! |
Hardy Diagnostics, 1430 West McCoy Lane, Santa Maria, CA, 93455, USA, +1.800.266.2222 |
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