Standard Operating Procedure for Aseptic

Standard Operating Procedure for Aseptic Processing – General Requirements

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Review period:Effective date + 35 months

A.   Purpose

The main purpose of standard operating procedure for aseptic processing is to lay down the prerequisite approach for the individual entering into the sterility testing area and aseptic processing area. Moreover, the purpose for the SOP is to lay down the approach of entry, exit and gowning approach in the aseptic area. The aim for SOP aseptic processing is to specify the personnel and environmental monitoring alert along with action level specifications for aseptic fulfilling events and contamination of investigation procedure after exceeding these levels.

B.   Scope

The scope for aseptic processing is suitable for sterility testing field of sterile injectable capacity and microbiology laboratory. The SOP is mainly applied for the qualified individuals only for controlling the entry, exit and aseptic area gowning. The process has applied in the Aseptic room 114K during the operations of aseptic filling.

C.   Responsibilities

The responsibility of following the principles of SOP for aseptic processing are demonstrated as follows.

Manufacturing department and quality control 

The role of manufacturing department and quality control departments is to perform environmental monitoring. Following the environmental guidelines is considered as the key responsibilities which is required to be followed.

The responsibility of manufacturing and quality control supervisors has focused on ensuring proper execution of job role of manufacturing and quality control executive through getting proper training and applying the monitoring procedures and equipment.

The role for quality control team is to approve the rejection of all the specifications or procedures which has impacted strength, identity, purity and quality of the drugs products.

The role of filter user is to review the validation information on the filter efficiency in production of sterile effluent filter.

Microbiology laboratory

The responsibility of microbiology department comprises supervision, conducting the media fill of aseptic area.

Personnel and environmental monitoring are accomplished during the fulfilment of aseptic media.

The microbiology department is also responsible for inspecting the filled units for detecting probable contamination which has investigated the root cause for the contamination.

Warehouse

The warehouse must maintain the needed inventory of the components of primary packaging and the nutrient media has needed by full program which is coordinated with quality assurance, production and microbiology department.

D.   Procedure

The procedure for the SOP of aseptic processing are followed through incorporating with certain stages which are demonstrated as follows.

  1. Checks

1.1 The entry towards aseptic area is completely restricted by the authorised qualified personnel according to the qualified and authorised personnel list which is displayed on the aseptic area entry.

The individuals who have suffered from aliments and infectious diseases like cough, cold and injury are not allowed for getting entry into the aseptic area(EUROPEAN COMMISSION, 2008).

The personal who have unhygienic conditions are absolutely not allowed for getting entry into the aseptic area and female citizens are not allowed to enter into the particular area.

  1. Sump area entry

After pressing the door-interlocking button, the door has opened and the individual must need to get enter into the sump area.

The plant footwear has removed which has kept them provided in shoe rack that is placed near almirah.

Removing the plant uniform and keeping them in the almirah are highlighted as the main process for getting entry into the sump area.

  1. Entrance into the first change room

Initially, the door-interlocking button has pressed and the individual must get entry into the first change room.

The disinfectant solution has kept in SS container which is filled in SS mug. After that, it has kept in SS trey and pour the solution on feet(WHO, 2011). It must be ensured that the solution dose must not be splashed out of the container.

Stepping on the provided protect mat in changed room and rising the hands with solution are highlighted as the next stages.

The individual must need to wear cap, trouser, shirt and booties and the trouser must not touch the ground for safety purpose.

  1. Entrance into the second change room

The door-interlocking button has pressed and the door of second change room has opened. The hands of individual has sanitized with disinfectant solution and the pre-sterilized hand gloves are kept in the perforated box(Picscheme, 2011). The hand gloves are incorporated and it must be ensure that the outer surface of gloves must not touch the bare hands.

  1. Entrance into the third changing room

The garment cubicle has opened and the sterile secondary garments has accomplished. The individual must wear the headgear without touching the outer surface. The boiler suit has needed to be handled in such a manner that the contact with floor must be avoided. The loose ends of the head cover must be tucked inside the suit and the boiler suit must be closed(Fda.gov, 2004). Discarding the empty bags in the change room waste bin are executed and looking into the mirror has also processed for reflecting proper gowning to ensure no exposition of any body parts.

  1. Entrance into the buffer changing room

The sanitisation of gloved hand with disinfectant solution has processed and picking up the secondary gloves from SS box provided over primary hand gloves has processed. The sterile passage has get penetrated by the individual.

  1. Entrance into cooling zone and sampling room

The user must get entry into the filling room and sampling room respectively.

  1. Exit approach from aseptic area

The user must address all the requirements and needs at their own position which has accomplish successful process of SOP of aseptic processing.

E.          Documentation and archiving

 

09-0035-SOP-1.0. Environmental Monitoring by applying biotest centrifugal air sampler

09-0036-SOP-1.0. Environmental Monitoring by applying RODAC plates

09-0037-SOP-1.0. Regular Environmental monitoring program in the context of manufacturing facility

09-0038-SOP-1.0. Aerosol counting applying MetOne 200L

The documents that are applied for developing aseptic fill environmental program are provided as follows.

Federal standard 209E

Pharmacopial Forum, Mar-Apr 1995, Page 440, Volume 21, Number 2 (1116) Microbiological Evaluation and Clean room or clean zone classification.

02-0031-PVP-1.0. Aseptic filling of process validation related to biotin conjugated murine which is characterised as Anti-Human CD34 Monoclonal antibody

Food and Drug Administration “Guideline on Sterile Drug Products formed by Aseptic processing” from June, 1987.

 

F.           Definitions

SOP – Standard Operating Procedure is considered as the particular set of stepwise instruction which are compiled by the business for helping the workers to carry out the complex pattern routine operations.

 

G.   Referenced documents

EUROPEAN COMMISSION, 2008. The Rules Governing Medicinal Products in the European Union. [Online]  Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf[Accessed 09 Jan 2020].

Fda.gov, 2004. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. [Online]  Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice[Accessed 09 Jan 2020].

Picscheme, 2011. RECOMMENDATION OF THE VALIDATION OF ASEPTIC PROCESSES. [Online]  Available at: https://picscheme.org/layout/document.php?id=153[Accessed 09 Jan 2020].

WHO, 2011. WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS .[Online] Available at: https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf;jsessionid=F66FF106EA0A7666A8A66982ED403828?sequence=1[Accessed 09 Jan 2020].

 

H.   Annexures

Proposed pattern of intervention at the time of media fill run

Worst Case Factor

 

 

 

 

Normal routine aseptic intervention

Normal condition of productionWorst scenario caseSelection Justification
Very few aseptic filling stoppageAseptic filling stoppage for adjusting the extended runtimeRising exposure time and sterility assurance contamination
Fill-weight checks in-processRising volume of in-process fill volume and fill weightSterility assurance and contamination risk
Powder filling vial inspection and samplingPowder filling and SCDM filling that is liquidExcess activity of SCDM filing hence for sterility assurance and contamination
Powder filling and hopper adjustmentAdjustment of hopper for powder and liquid fillingRisks associated with sterility assurance and contamination

 

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