@Y sctiteatincare Limits Quality Operations oa Document Code AHLTORSNOS/17/00 Microbiological Compressed Air Sampler Prentice Effective from: Date of Approval FUNCTION SIGNATURE. | DATE | Prodip Kumar Roy Microbiologist ey, 2L/o\/201%, Checked by : _ Md, Tusan Shahadat Sr RAD Executive [= |26 (a / ca Reviewer: | NA Approval: ‘A.BM. Mahfuz ul Alam GM, Quality Operations dy 2four> Note: Any unsigned document may not be considered as released by ACI HealthCare Lim Sonargaon, Narayanganj-1400, Bangladesh, other than for specified purposes such as pending approval. Each page of this document carries the document code and page number. The document is always re-versioned as a whole. Electronic sources of the material in this document are held under configuration control in ACI HealthCare Limited. Prey of At Hare Lak Furano pas conor ic com@) scrneatcare inte Cosy Opto User Requirements Specification Of Microbiological Compressed Air Sampler Document Code# AHL/URS/105/17/00 Paget 2 of 16 Requirements (BCSR) Vendors/Supplier's Responsibility (VSR) Operational Capabi . Capacity (CC) Functional Requirements (FR)... Hardware Requirements (HR)... Interface Requirements (IR). Data Control and Software Requirements @cse) Constraints... Regulatory Requirements (RR) Locations (LC).. Environmental Requirements (ER)... Electricity and Utility Requirements (EU} ‘Noise Level (NL) Validation Requirements (VR)... Safety Requirements (SR)... Support & Maintenance (SM), Training & Personnel Qualification (TPQ) . Documentation Requirement (DR) Vendor's Qualification (VQ)... ‘Timelines (TL).. Additional Requirements CAR) Glossary. References. Version/ Revision History... Contact... Prey of ACH Haan Lak For am quo come ioc bcmGY scrteancae inte User Requirements Specification OF Document Code AHLTURSI105/(7700 Microbiological Compressed Air Sampler Pagel 3 of 16 1. Introduction Microbiological monitoring of the compressed air is essential and imperative to avoid microbial contaminants inside controlled environments including production areas and clean rooms in a pharmaceutical industry. In most countries it is a regulatory requirement, and international standards have been published for bio-contamination control in clean rooms and other controlled environments, It can also form part of a compatible environmental monitoring program used alongside with the microbial active air samplers. For microbiological monitoring of Compressed air and process gases ean be sampled using specialized microbiological compressed air samplers that use Petri plates or Contact plates to capture any microorganisms .When the correct volume of air has been passed through the sampling head, the agar plate can be removed and incubated directly without further treatment, After incubation, counting the number of visible colonies gives a direct quantitative estimate of the number of colony forming units in the sampled air. 2. Purpose ‘The equipment will be used to perform environmental mot environmental microbial contamination. ing to determine the level of 3. Seope ‘The user requirement specification will be applicable for Microbiological Compressed Air sampler that will be used in Microbiology Laboratory of the Oral Solid Dose Manufacturing Unit at ACI HealthCare Limited. This format presents the basis for the indi follows: jual User Requirement Specification designated as BUS: Business - This is a business requirement CPP: Critical Process Parameter ~ A process parameter whose variability impacts a quality attribute and therefore needs to be controlled to ensure the process produces the desired quality. A critical process parameter remains critical even if itis controlled CQA: Critical Quality Attribute - A physical, chemical, biological or microbiological property or characteristic that needs to be controlled (directly or indirectly) to ensure product quality. CMA: Critical Material Attribute - A physical, chemical, biological or microbiological property or characteristic of a component, material or product contact surface that needs to be controlled (directly or indirectly) to ensure product quality. E: Essential - Designates an Essential item requirement for the Vendor. D: Desirable - Designates a Desirable item requirement for the Vendor. Prop of Cl Hear Lak Faron cnat noah coma) ‘ACI HealthCare Limited Quality Operations User Requirements Specification Of Document Code# AHLTURS/105717700 Microbiological Compressed Air Sampler Paget 4 of 16, i Optional ~ Designates an Optional item requirement for the Vendor. i | 4. Basie Configuration and System Requirements (BCSR) ; Priority URS ID Requirements BUS | cPP | CQA | CMA aq nt US | CI Q D/O) URS-BCSR-01 | Required quantity: 01. Vv E Should be portable, battery-driven | 1 URS-BCSR-02 | and light weight, ‘ | E URS-BCSR0s | Should be able to detection of false v D positive. | | URS.BCSR.04 | Should be capable of minimum 12 | j | a hours continuous operation | Should be compatible with common URS-BCSR-05 | sterilization and disinfection method. y E uRS-BcsR.06 | Should be capable of controling | y pressure of compressed gas. E Should have optimal design to ensure URS-BCSR-O7 | microorganisms are undamaged y E during sampling. Self contained unit consisting of connections, air flow meter, pressure | URS-BCSR-08 | cause, tap, funnel, head ‘complete 7 with plate housing. | 5. Vendors/Sup; URS ID Requirements us | cpp | cga | ema | PHority 2 D/O) | Supply, Design, Delivery and Testing i of defined operation under relevant | URS-VSR-01 | requirements of USP, ICH, EU and v Ip US FDA guidance, rules and reguk | Prope ef ACI Meore Lat Foran uch cat iat comQa ACI HealthCare Limited Quality Operations User Requirements Specification OF Document Code# AHL/URS/105/17/00 Microbiological Compressed Air Sampler Pagett 5 of 16 URS ID ‘Requirements BUS | CPP |CQa |CMA eo In the event of conflicting requirements in this URS, the Supplier/Vendor has to make the user URS-VSR-02 | aware of ~—the-—_conflicting | V E requirements, and Supplier/Vendor has to solve these conflicts in co- operation with the user. No modification/exceptions to this URS made by the Supplier/Vendor URS-VSR-03 _| will be accepted unless prior approval | ¥ E in writing has been received from user. Supplier must bring to the attention of the user any requirements of the documents which, in his opinion, are | URS-VSR-04 | not in accordance with applicable regulations, standards or required functionality. ‘Any faults or deficiencies found during installation, or commissioning must be notified to the user at shortest possible time and are to be| y corrected by Supplier at shortest possible time without additional cost. Where applicable documentation, URS-VSR-05 L drawings or tests must be revised. The equipment must be provided with suitable and adequate packaging | for protection against — weather, temperature extremes, pilferage and | | rough handling during transportation, off loading and final positioning up to and including installation and commissioning. URS-VSR-06 ‘All arrangements and costs off transport, insurance, taxes and duties URS-VSR-07 | required to deliver the equipment to | ¥ E the AHL facility should be included specifically into the quotation. Supplier /Vendor should supply, URS-VSR-08 | install & qualify the instrument as per | Vv E the international regulations, Pry of Cr Har Lak Faron roy Poca peanigect ScotQ ACI HealthCare Limited Quality Operations User Requirements Specification Of Microbiological Compressed Air Sampler Document Code# AHL/URS/105/17/00 Pagel! 6 of 16 URS ID Requirements Bus |cpp | cqa |cMa | Pe The Supplier/Vendor must confirm compliance with this URS, The Supplier/Vendor is required 10 -ysr.o9 | spond by confirming that the | » URS-VSR-09 | system complies fully 2 3 requirement or, if not in comy stating in what ways it | the requirements, | Supplier must be solely responsible for the supply of goods and services. | Supplier must ensure that the | equipment are suitable for what they . URS-VSR-10 | are intended, not withstanding | ¥ E anything inthe documents, comprising this specification. The supplier must not be relieved of responsibility under this clause. 6. Operational Capability 6.1 Capacity (CC) Tr ; | Priority URS ID Requirements Bus | cr | cqa [oma | fine [Required collected total sample | URS-CC-O1 | Volume minimum 1000 L. . Ie 6.2 Functional Requirements (FR) URS ID Requirements Bus | cpp | co | cma | Bi | uns-rr-or [Sampling Bow rte minimum 100) | : minutes. | URS-FR-02 | Sampling mode should be adjustable: | e volume or time, interval sampling {| URS-FR-03 | Maximum gas pressure: 5 to 7 bar | : It can collect air samples either on URS-FR-04 RODAC plates or Standard 90 mm | ¥ E Petri dishes. Pry of Ct Hear ag Faron oe ple na i aac2 ACI HealthCare Limited Quality Operations User Requirements Specification Of Microbiological Compressed Air Sampler ‘Document Code# AHL/URS/105/17700 Page# 7 of 16 URS ID Requirements Bus | CPP | CQA | CMA cae ey Unit requires no power and fully | y : URS-FRO5 | transportable. Y I 6.3 Hardware Requirements (HR) URS ID Requirements BUS | CPP | CQA | CMA oe “urcor | Eduipment placement shall conform URSHR-O! | to GMP, EMA and FDA regulations, | woe Should be autoclave-able sampling URS-HR-02 | head e.g. stainless steel 316L. ve 6.4 Interface Requirements (IR) ‘URS ID Requirements BUS | CPP | CQA: | CMA aah | User Interface Access levels There | should be 4 excess levels including URSIR-OL | Administrator, Engineer, Operator \v D and Supervisor. The control system shall include | interfaces with the User’s control URS Oe system to facilitate automatic y | a ‘operation and configuration. « ‘System should be able to interface fae ith EthernetIRS232 network cables. | Y oe Should have convenient URSIR-04 | rrogramming with glove-compatible v touch screen, _ URS-IR-05 | Should have data storage capacity. | V 3 6.5 Data Control and Software Requirements (DCSR) URS ID Requirements BUS | CPP | CQA | CMA oe i ‘Operation should be of touch control, URS-DCSR-O1 | bright LCD/LED display or PC |v D control. ‘ope fC ata Foray cp co fo comea ACI HealthCare Limited Quality Operation User Requirements Specification OF ‘Document Code# AHL/URS/105/17700 Microbiological Compressed Air Sampler Paget 8 of 16 “ Priority URS ID Requirements BUS | CPP | CQA | CMA | (nyo) 5 System’s Server and Software system URS-DCSR-02 | should be validated. _ wy System’s Server shall be SQL Server URS-DCSR-03 | Express, SQL Server, or Oracle | ¥ D technology. System should have ability to URS-DCSR-04 | generate accurate and complete | ¥ | | E copies of records, System should have record of | y operator entries. | URS-DCSR-06 | System should have access security. |v Use of operational system checks to URS-DCSR-07 | enforce permitted sequencing of steps | V E and events, as appropriate. URS-DCSR-0S There should be option for automated URS-DCSR-OB | catibration and calibration reminder. | yD | 1 Constraints 7.4 Regulatory Requirements (RR) URS ID Requirements Bus [cre |cga [ema | (one Supplier/Vendor shall stipulate the URS-RR-OL methods by which regulatory | ¥ E requirements are met. The System should meet limits as URS-RR-02 | defined by USP chapters :<797>, | V E <1116>, and 21 CFR compliance. The System should meet ASTM, EU URS-RR-03 | Guide for GMP, ISO 14698-1/2 and | V E ISO 8573-7. 7.2 Locations (LC) URSID Requirements Bus | cpp |cga | cma | Pure Prope of ACI Hen Lak Foran ch peak conse: Wait bomQ ACI HealthCare Limited Quality Operations ‘ser Requirements Specification OF Document Code AHLTURSIIOSII 7700 Microbiological Compressed Air Sampler =. URS ID Requirements BUS | CPP | CQA | cMA on ‘System Using Place: Latitude (DMS) 23°40°N; Longitude 7 URS-LC-01 (DMS) 90°33°E, v E Place: Sonargaon, Narayanganj, | | Bangladesh. | ~. System Altitude Position: URS-LC-02 | Altitude 32.4 M (approximately). _|Y E 7.3 Environmental Requirements (ER) URS ID Requirements Bus | cP | CQA | oma | (nie Must comply with the national as URS-ER-01 | well as international environmental | ¥ D | policies. 7.4 Electricity and Utility Requirements (EU) URS ID Requirements BUS | CPP | CQA | CMA es URS-EU-01 _| To be confirmed by vendor. v E 7.5 Noise Level (NL) ‘URS ID Rigihicmonts Bus | CPP | CQA | CMA 2D | ‘Noise Level will not exceed 73 dB URS-NL-01 | (Approx.) at one meter distance from | E the point of operation. Validation Requirements (VR) URSID ‘Requirements BUS | CPP | CQA | CMA eon Supplier/Vendor should provide assistance in qualification, routine URS-VR-Ol | Catiration, and timely repair through | ¥ y qualified people (Engineer/SME). Prope of 41 Hest La ‘ovary erp coma ia comQa ACI HealthCare Limited Quality Operations CL Document Code AFILTURSTVOSTI700 Microbiological Compressed Air Sampler licrobiological Comps d Air Sample Pages 10 of 16 URS ID Requirements BUS | CPP | cQA | CMa Ee Calibration of critical instruments, | gauges etc. as per the International URS-VR-02 guidelines along with NIST traceable Vv D calibration certificates. by the t qualified engineer or test lab. 9. Safety Requirements (SR) URS ID Requirements BUS | CPP | CQA | CMA nay ‘There should be no environmental URS-SR-O1 contamination with buil v D by any alternative mean, 10. Support & Maintenance (SM) URS ID ‘Requirements BUS | CPP | cQa | CMA pe) ‘Supplier/Vendor must have customer qv URS-SM-01 | feedback and response system in case E the user reports a problem or enhancement request. Tolerance limit of specific operation parameters are to be confirmed by supplier as well as enhance : URS-SM-02 | requirements of parts/spare parts but | ¥ e [not limited to safety and | maintenance a - Guarantee for spare pars should be URS-SM-03 | ctearly documented. v Z | Supplier to provide the recommended | | Spare Pars list and provide the Spare | ) | URS-SM-04 | parts that AHL has requested as part|Y | Ne of the system, | ‘Supplier/Vendor must provide phone | URS-SM-05 | and on-site support in ease of defects. |_| 7 ‘Supplier/Vendor must provide i information through the internet on| ) | URS-SM-06 | availability of new hardware/|‘ | y firmware/version ete. upgrades. Prey of At Hart Per anyuon peice ionic bomQa ‘ACI HealthCare Limited Quality Opera User Requirements Specification Of Microbiological Compressed Air Sampler Document Code# AHL/URS/105/17700 Pagel 11 of 16 11. Training & Personnel Qualification (TPQ) URS ID Requirements BUS CPP. | CQA CMA Priority. (E/DIO) URS-TPQ.01 ‘Training to be provided by Supplier engineer upon installation and start up. by an English speaking training | E URS-TPQ-02 Qualified personnel | of Supplier on operation, Calibration and maintenance. | should train atleast $ AHL personnel | ) 12, Documentation Requirement (DR) URS ID Requirements | BUS CPP | CQA Priority {E/DIO) URS-DR-01 t Documentation should be Supplier's by AHL and User has the right to ask for modifications prior to approval. | standard format, subject to approval ¥ URS-DR-02 Alll Certificates and Checklists must certificates for testing instruments shall show the period of validit be dated and signed. E.g. Calibration | y URS-DR-03 traceable. Each document should be uniquely | j URS-DR-04 ‘Any alterations or corrections to the documents should be initiated and dated. Corre used. Corrections must be made by deleting with a single line and signed and dated, n fluid should not be | URS-DR-05 ‘All documents shall be delivered | in Table 1. according to the project phase listed | ¥ URS-DR-06 ‘Supplier/Vendor should provide | qualification of SOP preparation. assistance in system operation and | ¥ URS-DR-07 Document Version Control controlled. Official documents shall be version | ¥ Pre of ACI Hei a Foray pes co fo ie com@ scrnteacare ini Quality Operations User Requirements Specification OF Microbiological Compressed Air Sampler ‘Document Code# AHL/URS/105/17700 Paget 12 of 16 URSID Requirements | Bus | cpp | cga | cma | Priority (E/D/O) Supplier/Vendor to provide the provided) URS-DR-08 | certificate for the Material of, E Construction (MoC) if required. 1Q, 0Q& PQ URS-DR-09 | (Original Documents should be E Table 1: Document List ‘Language| Document | | & SIN | Fomat i 2 3 gig 3 3) e)8 £/86/s)8) = 53 5\25|a\3\ 8) 1, | Equipment layout (including connection ‘AutoCAD or | ,, +__| points of utilities with dimension) Pdf | 2.__| Utility service requirements 3.__ | Project and quality plan 4___| Project schedule and milestones 5. | Functional Specification -__| (HDs,sDs,DDs) 6. P&IDs MS Word 7.___ | Quality Risk Assessment (QRA) ae i a 8.___| Factory Acceptance Test Draft Protocols 9. | Factory Acceptance Test Protocols __| 10. | Installation Qualification Draft Protocols LL. | Operational Qualification Draft Protocols 12, | Instruction Manual (operator, 7 | maintenance and service) 13. | Wiring Diagrams ‘AutoCAD or 14, _| Pneumatic and vacuum diagrams Pat 15. _| Spare Parts List 1 v 16. Instrument List a MS: Word | ‘Commercial component manuals and data] - | 2007 or above 17. = | orpdf v sheets _ am | OTP [18 [instattation Qualification Protocols a [ per ft ttc ik Fenny nt pa son Mob bom@Q ACI HealthCare Limited Quality Operations: ‘User Requirements Specification OF Document Code AHLIURSTOS/17100 Microbiological Compressed Air Sampler Paget 13 0f 16 ae Project Stage 3 3 SIN | Document Format i z S|s g idee 5 2 SISl 5 Be S\dslalalé Lubrication z Preventive maintenance schedule v 21 Operational Qualification Protocols v Calibration Schedule for critical measuring instruments PLC ladder logic preferable 7 Backup copy of software (e.g.: CD-ROM, Electronically memory card) readable 13. Vendor's Qualification (VQ) URS ID Requirements BUS | CPP | CQA | CMA ee ‘Vendor must provide documented | evidence that the system (parts of the | URS-VQ-01 | system) has been designed, | le developed and manufactured in a | quality environment. ‘Vendor must be capable of knowing | all critical parameters, qualifications, | URS-VQ02 | calibrations and maintenance of the | ¥ | B system, I | Vendor must meet AHL Vendor URS-VQ-03 | a.sessment procedural criteria y | B 14. Timelines (TL) URS ID Requirements BUS | CPP | CQA | CMA any Supplier/Vendors are requested to urs-rL-o1 | offer their best price based on these | . minimum requirements within 10 days upon receipt of this URS. Prop of Ct Hear La Faron guy pe cnat ioc comQa ACI HealthCare Limited Quality Operations User Requirements Specification OF Document Code# AHL/URS/105/17/00 Microbiological Compressed Air Sampler Paget 14 of 16 URS ID Requirements BUS | CPP | CQA | CMA Deo) Supplier/Vendors are requested to offer their anticipated timeline of URS-TL-02 Delivery, Commissioning and | ¥ D | Services in response of future purchase order. Supplier/Vendors are requested to URS-TL-03 | provide full support and warranty for || D 3 years. urs-11-04 | Supplier/Vendors are requested to | = deliver spare parts for 3 years. ‘The Supplier must provide onsite URS-TL-0S support within 24 hours (normal | ¥ E workdays), if required by AHL. | Software problem must be handled URS-TL-06 | by the manufacturer’s representative | ¥ D for up to 3 years or more, Delivery report should be given : URS-TL-O7 | within 1 month after confirmation. | ¥ a 15. Additional Requirements (AR) ; Priority cpp URS ID Requirements BUS. CQA | OMA | EDO) Supplier/Vendor should provide | | URS-AR-O1 | Calibration tools (NIST Traceable as | ¥ D applicable), E In the event of a power failure, the i system shall protect in the following 7 priority: | ereea | Pemomel y | E Equipments | ‘Apparatus. | System must have specific Recovery | 7 URS-AR-03_ | Methods such as manually re-start | ¥ based on operator inputs. urs-AR.o4 | Complete reproducibility of process | / EB cycles. ae URS-AR-05 | Carrying case. v F Proper of tHe Lak Foran que peteconac ms ohact beam2 ACI HealthCare Limited ey Document Code AHLTURS/105/17700 Microbiological Compressed Air Sampler Pagel 15 of 16 URS ID uirements c ot Req BUS | CPP | CQA | CMA (D/O) -ar-o6 | There should be option for automated | » | URS-AR-06 | calibration and calibration reminder. | V | y 16. Glossary Acronym Definition °c Degrees Celsius acl Advanced Chemical Industries AHL ACI Healtheare Limited ASTM ‘American Society For Testing And Materials BUS Business Requirements GMP Current Good Manufacturing Practice CMA Critical Material Attribute cep Critical Process Parameter CQA Critical Quality Attribute D Desired DB Decibels DMs Degrees Minutes Seconds E Essential EMA European Medicines Agency GAMP Good Automated Manufacturing Practice GLP Good Laboratory Practice GMP Good Manufacturing Practice oe ‘An abbreviation combining GCP, GLP, and GMP. Sometimes also called cGxP, Current Good Practices 1Q Installation Qualification Iso International Organization for Standard MoC Material of Construction NA Not Applicable ° Optional 0Q Operational Qualification PLC Programmable Logie Controller PQ Performance Qualification sps Software Design Specification pps ital Design Standards HDs Hardware Design Specifications sop Standard Operating Procedure USFDA United States Food and Drug Administration usP United States Pharmacopeia NIST National Institute of Standards and Technology Prope of AC Heath a Foran ques pes inact com2 ACI HealthCare Limited Quality Operations User Requirements Specification OF Document Code# AHL/URS/105/17/00 Microbiological Compressed Air Sampler Paget 16 of 16 17. References > 21 CER Parts 211: Current Good Manufacturing Practice for Pharmaceutical Products, » 21 CFR Parts 58: Current Good Laboratory Practice for Pharmaceutical Products. » ISO 14698-1, Clean rooms and associated controlled environments—Bio-contamination control, Part 1: General principles and methods. > ISO 14698-2, Clean rooms and associated controlled environments—Bio-contamination control, Part 2: Evaluation and interpretation of bio-contamination data. 1SO 8573-7: Micro Testing of Compressed Air. USP Chapter: <797> Pharmaceutical Compounding-Sterile Preparations. USP Chapter: <1116> Microbiological control and monitoring of aseptic processing environments. vvy 18. Version/ Revision History Document Details & | Superseded Revision/Change SN | Version Document No. | in brief Seer rns ol AHL/URS/105/17/00 | None None | Not Applicable 19, Contact In case of any query or confusion on any point of this URS, vendors are requested to contact with below responsible person: A. B.M. Mahfuz ul Alam General Manager, Quality Operations ‘ACI HealthCare d E-mail: mahfuz.alam@aci-bd.com Cell: +8801730021082 Proper ef Ct Heian at Foren euch ec eect