Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 25437) |
| Document Title [English] : | Aseptic Processing of Health Care Products Part 5 Sterilization in Place |
| Document Title [Hindi] : | स्वास्थ्य देखभाल उत्पादों का कीटाणु-नाशक प्रसंस्करण भाग 5 स्थान पर विसंक्रमण |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.080.01 |
| Date of Project Approval : | 25-04-2024 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Medical and Hospital Equipments |
| Sub Sub Group : | Allied hospital equipment |
| Aspects : | Process Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 13408-5:2006 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. | |
Timeline Details |
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Stages |
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| Sl. No. |
Stage | Date of Occurence | Remarks | Circulated to | Files |
| 1 | Generation of Document Number | 25-04-2024 | ------- | ||
| 2 | P-Draft Waived | 28-04-2024 | ISO Adoption | ------- | |
| 3 | WC Draft | 08-05-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 08-05-2024 | WC approved by HOD |
MHDC | ------- |